AGREEMENT
on mutual recognition between the European Community and the United States of America
Article 1
Definitions
Article 2
Purpose of the Agreement
Article 3
General obligations
Article 4
General coverage of the Agreement
Article 5
Transitional arrangements
Article 6
Designating Authorities
Article 7
Designation and listing procedures
Article 8
Suspension of listed conformity assessment bodies
Article 9
Withdrawal of listed conformity assessment bodies
Article 10
Monitoring of conformity assessment bodies
Article 11
Conformity assessment bodies
Article 12
Exchange of information
Article 13
Sectoral contact points
Article 14
Joint Committee of the Parties
Article 15
Preservation of regulatory authority
Article 16
Suspension of recognition obligations
Article 17
Confidentiality
Article 18
Fees
Article 19
Agreements with other countries
Article 20
Territorial application
Article 21
Entry into force, amendment and termination
Article 22
Final provisions
SECTORAL ANNEX FOR TELECOMMUNICATION EQUIPMENT
PREAMBLE
SECTION I
LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS
EC |
USA |
||||
Directive 98/13/EC of the European Parliament and of the Council of 12 February 1998 relating to telecommunications terminal equipment and satellite earth station equipment, including the mutual recognition of their conformity, and interpretation thereof; |
Communications Act of 1934, as amended by the Telecommunication Act of 1996, (Title 47 of the United States Code). The US regulatory and administrative provisions in respect of telecommunication equipment, including 47 CFR Part 68, and FCC interpretation thereof; |
||||
(The Parties recognize that the Handbook on the implementation of Directive 98/13/EC (ADLNB and ACTE approved), provides useful guidelines for the implementation of conformity assessment procedures falling under this Directive.); |
(The Parties recognize that the FCC Form 730 Application Guide provides useful guidelines for the implementation of conformity assessment procedures for telecommunication terminal equipment falling within these regulations.); |
||||
Commission Decisions (CTRs) established under Directive 98/13/EC; The EC Member States' legislation and regulations in respect of:
|
The US regulatory and administrative provisions in respect of all radio transmitters subject to an equipment authorisation requirement. A non-exclusive list of FCC regulations are contained in Section II; |
||||
For electrical safety, see Electrical Safety Sectoral Annex to the Agreement; |
For electrical safety, see Electrical Safety Sectoral Annex to the Agreement; |
||||
For electromagnetic compatibility aspects, see Electromagnetic Compatibility (EMC) Sectoral Annex to the Agreement. |
For electromagnetic compatibility aspects, see Electromagnetic Compatibility (EMC) Sectoral Annex to the Agreement. |
SECTION II
SCOPE AND COVERAGE
EC |
USA |
||||||||||||||||||||||||||||||||||||||||||||||||||||||
The following equipment categories are included: ISDN Basic Rate Access ISDN Primary Rate Access ISDN Telephony X21/V.24/V.35 Access X25 Access PSTN Non-Voice PSTN Voice Band (Analog) ONP Leased Line Terminal types:
|
Equipment categories covered under 47 CFR, Part 68, including: ISDN Basic Access ISDN Primary Rate Access Digital Service Access: 2.4 kbps 3.2 kbps (2.4 kbps with Secondary Channel) 4.8 kbps 6.4 kbps (4.8 kbps with SC) 9.6 kbps 12.8 kbps (9.6 kbps with SC) 19.2 kbps 25.0 kbps (19.2 kbps with SC) 56.0 kbps 64.0 kbps (uses 72 kbps channel) 72.0 kbps (56.0 kbps with SC) 1.544 Mbps 2-wire analog tie trunks/ops 4-wire analog tie trunks/ops PSTN-Voice Band (Analog) Access Private Line (Analog) Access |
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Radio transmitters subject to an equipment authorisation requirement, including:
|
Radio transmitters subject to an equipment authorisation requirement, including:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
Note: A list of acronyms and a glossary is contained in Appendix I to this Sectoral Annex. |
SECTION III
CONFORMITY ASSESSMENT PROCEDURES FOR TELECOMMUNICATION EQUIPMENT
1.
Description of Mutual Recognition Obligations
2.
Conformity Assessment Procedures
SECTION IV
AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V
EC |
USA |
||||||||||||||||||||||||||||||
|
National Institute of Standards and Technology (NIST) Federal Communications Commission (FCC) |
SECTION V
CONFORMITY ASSESSMENT BODIES
EC access to the US market |
US access to the EC market |
Conformity assessment bodies located in the EC shall be designated by the Authorities identified in Section IV following the procedures set out in Section VI of this Annex. |
Conformity assessment bodies located in the US shall be designated by the Authorities identified in Section IV following the procedures set out in Section VI of this Annex. |
(to be provided by the EC) |
(to be provided by the US) |
SECTION VI
DESIGNATING, LISTING, SUSPENDING, WITHDRAWING AND MONITORING CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V
EC access to the US market |
US access to the EC market |
EC Authorities identified in Section IV shall designate conformity assessment bodies located in the EC in accordance with the US legislative, regulatory, and administrative provisions identified in Section I that govern designation of conformity assessment bodies, based on compliance with the appropriate ISO/IEC Guides (e. g. Guide 22, 25, 28, 58, 61, 62, 65, etc.) or the comparable EN-45000 Series Standards. |
US Authorities identified in Section IV shall designate conformity assessment bodies located in the US in accordance with the EC legislative, regulatory, and administrative provisions identified in Section I that govern designation of conformity assessment bodies, based on compliance with the appropriate EN-45000 Series Standards or the comparable ISO/IEC Guides (e. g. 22, 25, 28, 58, 61, 62, 65, etc.) |
Procedures for designating, listing, suspending, withdrawing, and monitoring a conformity assessment body listed in Section V shall be undertaken pursuant to Articles 7, 8, 9 and 10 of the Agreement. |
Procedures for designating, listing, suspending, withdrawing, and monitoring a conformity assessment body listed in Section V shall be undertaken pursuant to Articles 7, 8, 9 and 10 of the Agreement. |
SECTION VII
ADDITIONAL PROVISIONS
1.
Sub-contracting
2.
Post-market surveillance, border measures and internal movement
3.
Joint Sectoral Committee
4.
Contact point
5.
Regulatory changes and updating the Sectoral Annex
SECTION VIII
TRANSITIONAL ARRANGEMENT
Appendix 1
Lists of acronyms and glossary
SECTORAL ANNEX FOR ELECTROMAGNETIC COMPATIBILITY (EMC)
PREAMBLE
SECTION I
LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS
EC |
USA |
||||
Council Directive 89/336/EEC, as amended by Council Directive 92/3 I/EEC, and Directive 98/13/EC of the European Parliament and of the Council and interpretation thereof. |
Communications Act of 1934, as amended by the Telecommunication Act of 1996, (Title 47 of the United States Code), The US regulatory and administrative provisions in respect of equipment subject to electromagnetic requirements including:
and FCC interpretation thereof. |
||||
For electrical safety aspects see Electrical Safety Sectoral Annex to the Agreement. |
For electrical safety aspects see Electrical Safety Sectoral Annex to the Agreement. |
||||
For telecommunication equipment and radio transmitters, see also Telecommunication Equipment Sectoral Annex to the Agreement. |
For telecommunication equipment and radio transmitters, see also Telecommunication Equipment Sectoral Annex to the Agreement. |
SECTION II
SCOPE AND COVERAGE
US access to the EC market |
EC access to the US market |
Any product falling under the scope of Council Directive 89/336/EEC. |
Any products falling under the scope of 47 CFR Part 15 and 18. |
SECTION III
CONFORMITY ASSESSMENT PROCEDURES FOR EQUIPMENT IDENTIFIED IN SECTION II
1.
Description of Mutual Recognition Obligations
2.
Conformity Assessment Procedures
SECTION IV
AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V
EC |
USA |
||||||||||||||||||||||||||||||
|
National Institute for Standards and Technology (NIST) Federal Communications Commission (FCC) Federal Aviation Administration (FAA) |
SECTION V
CONFORMITY ASSESSMENT BODIES
EC access to the US market |
US access to the EC market |
Conformity assessment bodies located in the EC shall be designated by the Authorities identified in Section IV following the procedures set out in Section VI of this Annex. |
Conformity assessment bodies located in the US shall be designated by the Authorities identified in Section IV following the procedures set out in Section VI of this Annex. |
(to be provided by the EC) |
(to be provided by the US) |
SECTION VI
DESIGNATING, LISTING, SUSPENDING, WITHDRAWING AND MONITORING CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V
EC access to the US market |
US access to the EC market |
EC Authorities identified in Section IV shall designate conformity assessment bodies located in the EC in accordance with the US legislative, regulatory, and administrative provisions identified in Section I that govern designation of conformity assessment bodies, based upon compliance with the appropriate ISO/IEC Guides (e.g. Guide 22, 25, 28, 58, 61, 62, 65, etc.) or the comparable EN-45000 Series Standards. |
US Authorities identified in Section IV shall designate conformity assessment bodies located in the US in accordance with the EC legislative, regulatory, and administrative provisions identified in Section I that govern designation of conformity assessment bodies, based on compliance with the appropriate EN-45000 Series Standards or the comparable ISO/IEC Guides (e.g. Guide 22, 25, 28, 58, 61, 62, 65, etc.). |
Procedures for designating, listing, suspending, withdrawing, and monitoring a conformity assessment body listed in Section V shall be undertaken pursuant to Articles 7, 8, 9, and 10 of the Agreement. |
Procedures for designating, listing, suspending, withdrawing, and monitoring a conformity assessment body listed in Section V shall be undertaken pursuant to Articles 7, 8, 9, and 10 of the Agreement. |
SECTION VII
ADDITIONAL PROVISIONS
1.
Sub-contracting
2.
Post-market surveillance, border measures and internal movement
3.
Joint Sectoral Committee
4.
Contact point
5.
Regulatory changes and updating the Sectoral Annex
SECTION VIII
TRANSITIONAL ARRANGEMENT
SECTORAL ANNEXFOR ELECTRICAL SAFETY
PREAMBLE
SECTION I
LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS
US access to the EC market |
EC access to the US market |
Council Directive 73/23/EEC of 19 February 1973 as amended by Directive 98/13/EC of the European Parliament and of the Council. |
29 USC 651 et seq. US 29 CFR 1910.7 Products that are certified or approved under the Federal Mine Safety and Health Act (30 USC 801 et seq.) or its regulations and used in areas under the authority of the Mine Safety and Health Administration, are not covered under this Annex. Occupational Safety and Health Administration (OSHA) will consider regulatory and legislative changes needed to support the objectives of the MRA. |
For medical devices, see the Medical Devices Sectoral Annex to this Agreement. |
For medical devices, see the Medical Devices Sectoral Annex to this Agreement. |
For electromagnetic compatibility aspects, see the Electromagnetic Compatibility (EMC) Sectoral Annex to this Agreement. |
For electromagnetic compatibility aspects, see the Electromagnetic Compatibility (EMC) Sectoral Annex to this Agreement. |
For telecommunication equipment, see the Telecommunication Equipment Sectoral Annex to this Agreement. |
For telecommunication equipment, see the Telecommunication Equipment Sectoral Annex to this Agreement. |
SECTION II
SCOPE AND COVERAGE
US access to the EC market |
EC access to the US market |
The electrical safety requirements of products falling under the scope of Council Directive 73/23/EEC on the harmonisation of the laws of the Member States relating to electrical equipment designed or use within certain voltage limits. |
The electrical safety requirements of products falling under the scope of 29 CFR 1910 subpart S. This includes the electrical safety aspects for workplace safety of medical equipment and telecommunication terminal equipment within the scope of those Sectoral Annexes. Products that are certified or approved under the Federal Mine Safety and Health Act (30 USC 801 et seq.) or its regulations and used in areas under the authority of the Mine Safety and Health Administration, are not covered under this Annex. |
SECTION III
DESCRIPTION OF MUTUAL RECOGNITION OBLIGATIONS
SECTION IV
AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V
EC access to the US market |
US access to the EC market |
||||||||||||||||||||
|
National Institute for Standards and Technology (NIST) |
||||||||||||||||||||
|
|
SECTION V
CONFORMITY ASSESSMENT BODIES
EC access to the US market |
US access to the EC market |
The names and scope of responsibilities of Conformity Assessment Bodies located in the EC and listed in accordance with this Sectoral Annex: |
The names and scope of responsibilities of Conformity Assessment Bodies located in the US and listed in accordance with this Sectoral Annex: |
(to the provided by the EC) |
(to be provided by the U.S.) |
SECTION VI
DESIGNATING, LISTING, SUSPENDING AND WITHDRAWING CONFORMITY ASSESSMENT BODIES
EC access to the US market |
US access to the EC market |
||||
Conformity assessment bodies from the EC shall be designated by the EC Authorities identified in Section IV and recognised by the Joint Committee, in accordance with the recognition procedures in the Agreement and this Annex. |
Conformity assessment bodies from the US shall be designated by the US Authority identified in Section IV and recognised by the Joint Committee, in accordance with the recognition procedures in the Agreement and Council Directive 73/23/EEC. |
||||
Conformance with the appropriate ISO/IEC Guides or the corresponding EN-45000 series of standards shall be deemed consistent with US requirements identified in Section I. |
Conformance with the appropriate EN-45000 series of standards or the corresponding ISO/IEC Guides shall be deemed consistent with the requirements of Council Directive 73/23/EEC. |
||||
For purposes of designation and listing, EC Designating Authorities identified in Section IV shall designate conformity assessment bodies located in the EC by filing a properly prepared proposal for listing, which includes a complete lab assessment under the US OSHA procedures. OSHA shall notify the EC Designating Authority normally within 30 days as to whether the proposal is complete or whether additional information is required. |
For purposes of designating and listing, the US Designating Authority identified in Section IV shall designate conformity assessment bodies located in the US by filing a properly prepared proposal for listing with the EC, which includes a complete lab assessment under the following EC or Member State procedures, as appropriate. |
||||
OSHA shall rely on the EC Designating Authorities identified in Section IV for conducting on-site reviews at the respective Member States' conformity assessment bodies. |
The EC shall notify the US Designating Authority within 30 days as to whether the proposal is complete and shall indicate, where applicable, any additional information that is required. |
||||
Upon receipt of a complete proposal, the US exercising its authority under its law shall:
These listing procedures shall supersede the procedures in Article 7(c) of the Agreement in its entirety and the time periods set out in Article 7(d) of the Agreement. |
Upon receipt of a complete proposal, the EC shall give notice of consent or objection to the Joint Committee within 60 days. The Joint Committee shall monitor the recognition of conformity assessment bodies and confirm such a recognition by listing them in Section V of this Sectoral Annex. |
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EC conformity assessment bodies listed in Section V shall have NRTL status in the US. |
The US conformity assessment bodies listed in Section V shall have Notified Body status within the EC. |
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With regard to the suspension of a conformity assessment body listed in this Sectoral Annex, the period specified in Article 8(e) of the Agreement shall begin to run after a Party has notified the Joint Sectoral Committee or the Joint Committee, pursuant to Article 8(c) of the Agreement, that it proposes to revoke the conformity assessment body's recognition in accordance with its procedures under its applicable domestic law. Except as provided for in this Section, procedures for designation, listing, suspension and withdrawal of conformity assessment bodies under this Sectoral Annex shall be carried out in accordance with Articles 7, 8 and 9 of the Agreement. |
|
SECTION VII
JOINT SECTORAL COMMITTEEFORELECTRICAL SAFETY
SECTORAL ANNEX FOR RECREATIONAL CRAFT
PREAMBLE
SECTION I
LEGISLATIVE, REGULATORY, AND ADMINISTRATIVE REQUIREMENTS
SECTION II
SCOPE AND COVERAGE
SECTION III
AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES
EC access to the US market |
US access to the EC market |
||||||||||||||||||
|
National Institute for Standards and Technology (NIST) |
SECTION IV
DESIGNATING, LISTING, SUSPENDING AND WITHDRAWING CONFORMITY ASSESSMENT BODIES
SECTION V
CONFORMITY ASSESSMENT BODIES
EC access to the US market |
US access to the EC market |
The names and scope of responsibilities of Conformity Assessment Bodies located in the EC and listed in accordance with this Sectoral Annex: |
The names and scope of responsibilities of Conformity Assessment Bodies located in the US and listed in accordance with this Sectoral Annex: |
(to be provided by EC) |
(to be provided by the US) |
SECTION VI
TRANSITIONAL ARRANGEMENT
SECTION VII
ADDITIONAL PROVISIONS
SECTION VIII
DEFINITIONS
SECTORAL ANNEX FOR PHARMACEUTICAL GOOD MANUFACTURING PRACTICES (GMPs)
PREAMBLE
CHAPTER 1
DEFINITIONS, PURPOSE, SCOPE AND COVERAGE
Article 1
Definitions
Article 2
Purpose
Article 3
Scope
Article 4
Product coverage
CHAPTER 2
TRANSITION PERIOD
Article 5
Length of transition period
Article 6
Equivalence assessment
Article 7
Participation in the equivalence assessment and determination
Article 8
Other transition activities
CHAPTER 3
END OF TRANSITION PERIOD
Article 9
Equivalence determination
Article 10
Authorities not currently listed as equivalent
CHAPTER 4
OPERATIONAL PERIOD
Article 11
Start of the operational period
Article 12
Nature of recognition of inspection reports
Article 13
Transmission of post-approval inspection reports
Article 14
Transmission of pre-approval inspection reports
Article 15
Monitoring continued equivalence
Article 16
Suspension
CHAPTER 5
JOINT SECTORAL COMMITTEE
Article 17
Role and composition of the Joint Sectoral Committee
CHAPTER 6
INFORMATION EXCHANGE
Article 18
Regulatory collaboration
Article 19
Information relating to quality aspects
Article 20
Alert System
CHAPTER 7
SAFEGUARD CLAUSE
Article 21
Appendix 1
List of applicable laws, regulations and administrative provisions
Appendix 2
List of Authorities
BELGIUM |
Inspection générale de la Pharmacie Algemene Farmaceutische Inspectie |
DENMARK |
Lægemiddelstyrelsen |
GERMANY |
Bundesministerium für Gesundheit |
GREECE |
Εθνικός Οργανισμός Φαρμάκου Ministry of Health and Welfare National Drug Organization (E.O.F) |
SPAIN |
for medicinal products for human use: Ministerio de Sanidad y Consumo Subdirección General de Control Farmacéutico for medicinal products for veterinary use: Ministerio de Agricultura, Pesca y Alimentación (MAPA) Dirección General de la Producción Agraria |
FRANCE |
for medicinal products for human use: Agence du Médicament for veterinary medicinal products: Agence Nationale du Médicament Vétérinaire |
IRELAND |
Irish Medicines Board |
ITALY |
for medicinal products for human use: Ministero della Sanità Dipartimento Farmaci e Farmacovigilanza for medicinal products for veterinary use: Ministero della Sanità Dipartimento alimenti e nutrizione e sanità pubblica veterinaria — Div. IX |
LUXEMBOURG |
Division de la Pharmacie et des Médicaments |
NETHERLANDS |
Staat der Nederlanden |
AUSTRIA |
Bundesministerium für Arbeit, Gesundheit und Soziales |
PORTUGAL |
for human and veterinary (non-immunologicals): Instituto da Farmácia e do Medicamento — INF ARMED for veterinary immunologicals: Direcção — Geral de Veterinaria |
FINLAND |
Lääkelaitos/Läkemedelsverket (National Agency for Medicines) |
SWEDEN |
Läkemedelsverket — Medical Products Agency |
UNITED KINGDOM |
for human and veterinary (non-immunologicals): Medicines Control Agency for veterinary immunologicals: Veterinary Medicines Directorate |
EUROPEAN COMMUNITY |
Commission of the European Communities European Agency for the Evaluation of Medicinal Products (EMEA) |
Appendix 3
Indicative list of Products covered by the Sectoral Annex
Appendix 4
Criteria for Assessing Equivalence for Post- and Pre-Approval
Appendix 5
Elements to be Considered in Developing a Two-way Alert System
1.
Documentation
2.
Crisis Management System
3.
Enforcement Procedures
4.
Quality Assurance System
5.
Contact points
SECTORAL ANNEX ON MEDICAL DEVICES
PREAMBLE
CHAPTER 1
PURPOSE, SCOPE AND COVERAGE OF THE SECTORAL ANNEX
Article 1
Purpose
Article 2
Scope
Article 3
Product Coverage
Article 4
Regulatory Authorities
CHAPTER 2
TRANSITION PERIOD
Article 5
Length and purpose of transition period
Article 6
Listing of CABs
Article 7
Confidence Building Activities
Article 8
Other transition period activities
CHAPTER 3
END OF TRANSITION PERIOD
Article 9
Equivalence Assessment
CHAPTER 4
OPERATIONAL PERIOD
Article 10
Start of the operational period
Article 11
Exchange and endorsement of quality system evaluation reports
Article 12
Exchange and endorsement of product evaluation reports
Article 13
Transmission of quality system evaluation reports
Article 14
Transmission of product evaluation reports
Article 15
Monitoring continued equivalence
Article 16
Listing of Additional CABs
CHAPTER 5
JOINT SPECIAL COMMITTEE
Article 17
Role and composition of the Joint Sectoral Committee
CHAPTER 6
HARMONISATION AND INFORMATION EXCHANGE
Article 18
Harmonisation
Article 19
Regulatory cooperation
Article 20
Alert system and exchange of post-market vigilance reports
Appendix 1
Relevant legislation, regulations and procedures
Appendix 2
Scope of product coverage
Section No |
Regulation Name Product Code — Device Name |
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ANESTHESIOLOGY PANEL (868) |
||||||||||||||||||||||||||||||||||||||||||||||||||||
868.1910 |
Esophageal stethoscope
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
868.5620 |
Breathing mouthpiece
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
868.5640 |
Medicinal nonventilatory nebulizer (atomizer)
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
868.5675 |
Rebreathing device
|
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868.5700 |
Nonpowered oxygen tent
|
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868.6810 |
Tracheobronchial suction catheter
|
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CARDIOVASCULAR PANEL |
||||||||||||||||||||||||||||||||||||||||||||||||||||
(None) |
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DENTAL PANEL (872) |
||||||||||||||||||||||||||||||||||||||||||||||||||||
872.3400 |
Karaya and sodium borate with or without acacia denture adhesive
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
872.3700 |
Dental mercury (USP)
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
872.4200 |
Dental handpieces and accessories
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
872.6640 |
Dental operative unit
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
EAR, NOSE, AND THROAT PANEL (874) |
||||||||||||||||||||||||||||||||||||||||||||||||||||
874.1070 |
Short increment sensitivity index (SISI) adapter
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
874.1500 |
Gustometer
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
874.1800 |
Air or water caloric stimulator
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
874.1925 |
Toynbee diagnostic tube
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
874.3300 |
Hearing aid
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
874.4100 |
Epistaxis balloon
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
874.5300 |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
874.5550 |
Powered nasal irrigator
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
874.5840 |
Anti-stammering device
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
GASTROENTEROLOGY — UROLOGY PANEL (876) |
||||||||||||||||||||||||||||||||||||||||||||||||||||
876.5160 |
Urological clamps for males
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
876.5210 |
Enema kit
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
876.5250 |
Urine collector and accessories
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
GENERAL HOSPITAL PANEL (880) |
||||||||||||||||||||||||||||||||||||||||||||||||||||
880.5270 |
Neonatal eye pad
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
880.5420 |
Pressure infuser for I.V. bag
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
880.5680 |
Pediatric position holder
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
880.6250 |
Patient examination glove
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
880.6375 |
Patient lubricant
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
880.6760 |
Protective restraint
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
NEUROLOGY PANEL (882) |
||||||||||||||||||||||||||||||||||||||||||||||||||||
882.1030 |
Ataxiagraph
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
882.1420 |
Electroencephalogram (EEG) signal spectrum analyser
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
882.4060 |
Ventricular cannula
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
882.4545 |
Shunt system implantation instrument
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
882.4650 |
Neurosurgical suture needle
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
882.4750 |
Skull punch
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
OBSTETRICS AND GYNECOLOGY PANEL |
||||||||||||||||||||||||||||||||||||||||||||||||||||
(None) |
||||||||||||||||||||||||||||||||||||||||||||||||||||
OPHTHALMOLOGY PANEL (886) |
||||||||||||||||||||||||||||||||||||||||||||||||||||
886.1780 |
Retinoscope
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
886.1940 |
Tonometer sterilizer
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
886.4070 |
Powered corneal burr
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
886.4300 |
Keratone
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
886.5850 |
Sunglasses (non-prescription)
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
ORTHOPEDIC PANEL (888) |
||||||||||||||||||||||||||||||||||||||||||||||||||||
888.1500 |
Ac-powered goniometer
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
888.4150 |
Callipers for clinical use
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
PHYSICAL MEDICINE PANEL (890) |
||||||||||||||||||||||||||||||||||||||||||||||||||||
890.3850 |
Mechanical wheelchair
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
890.5180 |
Manual patient rotation bed
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
890.5710 |
Hot or cold disposable pack
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
RADIOLOGY PANEL (892) |
||||||||||||||||||||||||||||||||||||||||||||||||||||
892.1100 |
Scintillation gamma camera
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
892.1110 |
Positron camera
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
892.1300 |
Nuclear rectilinear scanner
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
892.1320 |
Nuclear uptake probe
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
892.1330 |
Nuclear whole body scanner
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
892.1410 |
Nuclear electrocardiograph synchroniser
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
892.1890 |
Radiographic-film illuminator
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
892.1910 |
Radiographic grid
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
892.1960 |
Radiographic intensifying screen
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
892.1970 |
Radiographic ECG/respirator synchroniser
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
892.5650 |
Manual radionuclide applicator system
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
GENERAL AND PLASTIC SURGERY PANEL (878) |
||||||||||||||||||||||||||||||||||||||||||||||||||||
878.4200 |
Introduction/drainage catheter and accessories
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
878.4320 |
Removable skin clip
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
878.4460 |
Surgeon's gloves
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
878.4680 |
Nonpowered, single patient, portable suction apparatus
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
878.4760 |
Removable skin staple
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
878.4820 |
Ac-powered, battery-powered, and pneumatically powered surgical instrument motor
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
878.4960 |
Air or ac-powered operating table and air or ac-powered operating chair and accessories
|
|||||||||||||||||||||||||||||||||||||||||||||||||||
880.5090 |
Liquid bandage
|
RA |
892.1000 |
Magnetic resonance diagnostic device
|
|||||||||||||||||||||||||||||||||||||||||||||
DIAGNOSTIC ULTRASOUND |
|||||||||||||||||||||||||||||||||||||||||||||||
RA |
892.1540 |
Nonfetal ultrasonic monitor
|
|||||||||||||||||||||||||||||||||||||||||||||
RA |
892.1550 |
Ultrasonic pulsed doppler imaging system
|
|||||||||||||||||||||||||||||||||||||||||||||
RA |
892.1560 |
Ultrasonic pulsed echo imaging system
|
|||||||||||||||||||||||||||||||||||||||||||||
RA |
892.1570 |
Diagnostic ultrasonic transducer
|
|||||||||||||||||||||||||||||||||||||||||||||
DIAGNOSTIC X — RAY IMAGING DEVICES |
|||||||||||||||||||||||||||||||||||||||||||||||
(except mammographic x-ray systems) |
|||||||||||||||||||||||||||||||||||||||||||||||
RA |
892.1600 |
Angiographic x-ray system
|
|||||||||||||||||||||||||||||||||||||||||||||
RA |
892.1650 |
Image-intensified fluoroscopic x-ray system
|
|||||||||||||||||||||||||||||||||||||||||||||
RA |
892.1680 |
Stationary x-ray system
|
|||||||||||||||||||||||||||||||||||||||||||||
RA |
892.1720 |
Mobile x-ray system
|
|||||||||||||||||||||||||||||||||||||||||||||
RA |
892.1740 |
Tomographic x-ray system
|
|||||||||||||||||||||||||||||||||||||||||||||
RA |
892.1750 |
Computed tomography x-ray system
|
|||||||||||||||||||||||||||||||||||||||||||||
ECG-RELATED DEVICES |
|||||||||||||||||||||||||||||||||||||||||||||||
CV |
870.2340 |
Electrocardiograph
|
|||||||||||||||||||||||||||||||||||||||||||||
CV |
870.2350 |
Electrocardiograph lead switching adaptor
|
|||||||||||||||||||||||||||||||||||||||||||||
CV |
870.2360 |
Electrocardiograph electrode
|
|||||||||||||||||||||||||||||||||||||||||||||
CV |
870.2370 |
Electrocardiograph surface electrode tester
|
|||||||||||||||||||||||||||||||||||||||||||||
NE |
882.1400 |
Electroencephalograph
|
|||||||||||||||||||||||||||||||||||||||||||||
HO |
880.5725 |
Infusion pump (external only)
|
|||||||||||||||||||||||||||||||||||||||||||||
OPHTHALMIC INSTRUMENTS |
|||||||||||||||||||||||||||||||||||||||||||||||
OP |
886.1570 |
Ophthalmoscope
|
|||||||||||||||||||||||||||||||||||||||||||||
OP |
886.1780 |
Retinoscope
|
|||||||||||||||||||||||||||||||||||||||||||||
OP |
886.1850 |
Ac-powered slit-lamp biomicroscope
|
|||||||||||||||||||||||||||||||||||||||||||||
OP |
886.4150 |
Vitreous aspiration and cutting instrument
|
|||||||||||||||||||||||||||||||||||||||||||||
OP |
886.4670 |
Phacofragmentation system
|
|||||||||||||||||||||||||||||||||||||||||||||
SU |
878.4580 |
Surgical lamp
|
|||||||||||||||||||||||||||||||||||||||||||||
NE |
882.5890 |
Transcutaneous electrical nerve stimulator for pain relief
|
|||||||||||||||||||||||||||||||||||||||||||||
NON-INVASIVE BLOOD PRESSURE MEASUREMENT DEVICES |
|||||||||||||||||||||||||||||||||||||||||||||||
CV |
870.1120 |
Blood pressure cuff
|
|||||||||||||||||||||||||||||||||||||||||||||
CV |
870.1130 |
Non-invasive blood pressure measurement system (except non-oscillometric)
|
|||||||||||||||||||||||||||||||||||||||||||||
HO |
880.6880 |
Steam steriliser (greater than 2 cubic feet)
|
|||||||||||||||||||||||||||||||||||||||||||||
CLINICAL THERMOMETERS |
|||||||||||||||||||||||||||||||||||||||||||||||
HO |
880.2910 |
Clinical electronic thermometer (except tympanic or pacifier)
|
|||||||||||||||||||||||||||||||||||||||||||||
AN |
868.5630 |
Nebuliser
|
|||||||||||||||||||||||||||||||||||||||||||||
AN |
868.5925 |
Powered Emergency ventilator |
|||||||||||||||||||||||||||||||||||||||||||||
HYPODERMIC NEEDLES AND SYRINGES |
|||||||||||||||||||||||||||||||||||||||||||||||
(except anti-stick and self-destruct) |
|||||||||||||||||||||||||||||||||||||||||||||||
HO |
880.5570 |
Hypodermic single lumen needle
|
|||||||||||||||||||||||||||||||||||||||||||||
HO |
880.5860 |
Piston syringe
|
|||||||||||||||||||||||||||||||||||||||||||||
OR |
888.3020 |
Intramedullary fixation rod
|
|||||||||||||||||||||||||||||||||||||||||||||
EXTERNAL FIXATORS |
|||||||||||||||||||||||||||||||||||||||||||||||
(except devices with no external components) |
|||||||||||||||||||||||||||||||||||||||||||||||
OR |
888.3030 |
Single/multiple component metallic bone fixation appliances and accessories
|
|||||||||||||||||||||||||||||||||||||||||||||
OR |
888.3040 |
Smooth or threaded metallic bone fixation fastener
|
|||||||||||||||||||||||||||||||||||||||||||||
SELECTED DENTAL MATERIALS |
|||||||||||||||||||||||||||||||||||||||||||||||
DE |
872.3060 |
Gold based alloys and precious metal alloys for clinical use
|
|||||||||||||||||||||||||||||||||||||||||||||
DE |
872.3200 |
Resin tooth bonding agent
|
|||||||||||||||||||||||||||||||||||||||||||||
DE |
872.3275 |
Dental cement
|
|||||||||||||||||||||||||||||||||||||||||||||
DE |
872.3660 |
Impression material
|
|||||||||||||||||||||||||||||||||||||||||||||
DE |
872.3690 |
Tooth shade resin material
|
|||||||||||||||||||||||||||||||||||||||||||||
DE |
872.3710 |
Base metal alloy
|
|||||||||||||||||||||||||||||||||||||||||||||
LATEX CONDOMS |
|||||||||||||||||||||||||||||||||||||||||||||||
OB |
884.5300 |
Condom
|
Product Family |
Section No |
Device Name |
Tier |
ANAESTHESIOLOGY PANEL |
|||
Anesthesia Devices |
868.5160 |
Gas machine for anesthesia or analgesia |
2 |
868.5270 |
Breathing system heater |
2 |
|
868.5440 |
Portable oxygen generator |
2 |
|
868.5450 |
Respiratory gas humidifier |
2 |
|
868.5630 |
Nebuliser |
2 |
|
868.5710 |
Electrically powered oxygen tent |
2 |
|
868.5880 |
Anesthetic vaporiser |
2 |
|
Gas Analyzer |
868.1040 |
Powered Algesimeter |
2 |
868.1075 |
Argon gas analyser |
2 |
|
868.1400 |
Carbon dioxide gas analyser |
2 |
|
868.1430 |
Carbon monoxide gas analyser |
2 |
|
868.1500 |
Enflurane gas analyser |
2 |
|
868.1620 |
Halothane gas analyser |
2 |
|
868.1640 |
Helium gas analyser |
2 |
|
868.1670 |
Neon gas analyser |
2 |
|
868.1690 |
Nitrogen gas analyser |
2 |
|
868.1700 |
Nitrous oxide gas analyser |
2 |
|
868.1720 |
Oxygen gas analyser |
2 |
|
868.1730 |
Oxygen uptake computer |
2 |
|
Peripheral Nerve Stimulators |
868.2775 |
Electrical peripheral nerve stimulator |
2 |
Respiratory Monitoring |
868.1750 |
Pressure plethysmograph |
2 |
868.1760 |
Volume plethysmograph |
2 |
|
868.1780 |
Inspiratory airway pressure meter |
2 |
|
868.1800 |
Rhinoanemometer |
2 |
|
868.1840 |
Diagnostic spirometer |
2 |
|
868.1850 |
Monitoring spirometer |
2 |
|
868.1860 |
Peak-flow meter for spirometry |
2 |
|
868.1880 |
Pulmonary-function data calculator |
2 |
|
868.1890 |
Predictive pulmonary-function value calculator |
2 |
|
868.1900 |
Diagnostic pulmonary-function interpretation calculator |
2 |
|
868.2025 |
Ultrasonic air embolism monitor |
2 |
|
868.2375 |
Breathing frequency monitor (except apnea detectors) |
2 |
|
868.2480 |
Cutaneous carbon dioxide (PcCO2) monitor |
2 |
|
868.2500 |
Cutaneous oxygen monitor (for an infant not under gas anesthesia) |
2 |
|
868.2550 |
Pneumotachomometer |
2 |
|
868.2600 |
Airway pressure monitor |
2 |
|
868.5665 |
Powered percussor |
2 |
|
868.5690 |
Incentive spirometer |
2 |
|
Ventilator |
868.5905 |
Nonconinuous ventilator (IPPB) |
2 |
868.5925 |
Powered emergency ventilator |
2 |
|
868.5935 |
External negative pressure ventilator |
2 |
|
868.5895 |
Continuous ventilator |
2 |
|
868.5955 |
Intermittent mandatory ventilation attachment |
2 |
|
868.6250 |
Portable air compressor |
2 |
|
CARDIOVASCULAR PANEL |
|||
Cardiovascular Diagnostic |
870.1425 |
Programmable diagnostic computer |
2 |
870.1450 |
Densitometer |
2 |
|
870.2310 |
Apex cardiograph (vibrocardiograph) |
2 |
|
870.2320 |
Ballistocardiograph |
2 |
|
870.2340 |
Electrocardiograph |
2 |
|
870.2350 |
Electrocardiograph lead switching adaptor |
1 |
|
870.2360 |
Electrocardiograph electrode |
2 |
|
870.2370 |
Electrocardiograph surface electrode tester |
2 |
|
870.2400 |
Vectorcardiograph |
1 |
|
870.2450 |
Medical cathode-ray tube display |
1 |
|
870.2675 |
Oscillometer |
2 |
|
870.2840 |
Apex cardiographic transducer |
2 |
|
870.2860 |
Heart sound transducer |
2 |
|
Cardiovascular Monitoring |
|
Valve, pressure relief, cardiopulmonary bypass |
|
870.1100 |
Blood pressure alarm |
2 |
|
870.1110 |
Blood pressure computer |
2 |
|
870.1120 |
Blood pressure cuff |
2 |
|
870.1130 |
Non-invasive blood pressure measurement system |
2 |
|
870.1140 |
Venous blood pressure manometer |
2 |
|
870.1220 |
Electrode recording catheter or electrode recording probe |
2 |
|
870.1270 |
Intracavitary phonocatheter system |
2 |
|
870.1875 |
Stethoscope (electronic) |
2 |
|
870.2050 |
Biopotential amplifier and signal conditioner |
2 |
|
870.2060 |
Transducer signal amplifier and conditioner |
2 |
|
870.2100 |
Cardiovascular blood flow-meter |
2 |
|
870.2120 |
Extravascular blood flow probe |
2 |
|
870.2300 |
Cardiac monitor (including) cardiotachometer and rate alarm) |
2 |
|
870.2700 |
Oximeter |
2 |
|
870.2710 |
Ear oximeter |
2 |
|
870.2750 |
Impedance phlebograph |
2 |
|
870.2770 |
Impedance plethysmograph |
2 |
|
870.2780 |
Hydraulic, pneumatic, or photoelectric plethysmographs |
2 |
|
870.2850 |
Extravascular blood pressure transducer |
2 |
|
870.2870 |
Catheter tip pressure transducer |
2 |
|
870.2880 |
Ultrasonic transducer |
2 |
|
870.2890 |
Vessel occlusion transducer |
2 |
|
870.2900 |
Patient transducer and electrode cable (including connector) |
2 |
|
870.2910 |
Radiofrequency physiological signal transmitter and receiver |
2 |
|
870.2920 |
Telephone electrocardiograph transmitter and receiver |
2 |
|
870.4205 |
Cardiopulmonary bypass bubble detector |
2 |
|
870.4220 |
Cardiopulmonary bypass heart-lung machine console |
2 |
|
870.4240 |
Cardiovascular bypass heat exchanger |
2 |
|
870.4250 |
Cardiopulmonary bypass temperature controller |
2 |
|
870.4300 |
Cardiopulmonary bypass gas control unit |
2 |
|
870.4310 |
Cardiopulmonary bypass coronary pressure gauge |
2 |
|
870.4330 |
Cardiopulmonary bypass on-line blood gas monitor |
2 |
|
870.4340 |
Cardiopulmonary bypass level sensing monitor and/or control |
2 |
|
870.4370 |
Roller-type cardiopulmonary bypass blood pump |
2 |
|
870.4380 |
Cardiopulmonary bypass pump speed control |
2 |
|
870.4410 |
Cardiopulmonary bypass in-line blood gas sensor |
2 |
|
Cardiovascular Therapeutic |
870.5050 |
Patient care suction apparatus |
2 |
870.5900 |
Thermal regulation system |
2 |
|
Defibrillator |
870.5300 |
DC-defibrillator (including paddles) |
2 |
870.5325 |
Defibrillator tester |
2 |
|
Echocardiograph |
870.2330 |
Echocardiograph |
2 |
Pacemaker and Accessories |
870.1750 |
External programmable pacemaker pulse generator |
2 |
870.3630 |
Pacemaker generator function analyser |
2 |
|
870.3640 |
Indirect pacemaker generator function anlayser |
2 |
|
870.3720 |
Pacemaker electrode function tester |
2 |
|
Miscellaneous |
870.1800 |
Withdrawal-infusion pump |
2 |
870.2800 |
Medical magnetic tape recorder |
2 |
|
None |
Batteries, rechargeable, Class II devices |
2 |
|
DENTAL PANEL |
|||
Dental Equipment |
872.1720 |
Pulp tester |
2 |
872.1740 |
Caries detection device |
2 |
|
872.4120 |
Bone cutting instrument and accessories |
2 |
|
872.4465 |
Gas-powered jet injector |
2 |
|
872.4475 |
Spring-powered jet injector |
2 |
|
872.4600 |
Intraoral ligature and wire lock |
2 |
|
872.4840 |
Rotary scaler |
2 |
|
872.4850 |
Ultrasonic scaler |
2 |
|
872.4920 |
Dental electrosurgical unit and accessories |
2 |
|
872.6070 |
Ultraviolet activator for polymerisation |
2 |
|
872.6350 |
Ultraviolet detector |
2 |
|
Dental Material |
872.3050 |
Amalgam alloy |
2 |
872.3060 |
Gold-based alloys and precious metal alloys for clinical use |
2 |
|
872.3200 |
Resin tooth bonding agent |
2 |
|
872.3250 |
Calcium hydroxide cavity liner |
2 |
|
872.3260 |
Cavity varnish |
2 |
|
872.3275 |
Dental cement (other than zinc oxide-eugenol) |
2 |
|
872.3300 |
Hydrophilic resin coating for dentures |
2 |
|
872.3310 |
Coating material for resin fillings |
2 |
|
872.3590 |
Preformed plastic denture tooth |
2 |
|
872.3660 |
Impression material |
2 |
|
872.3690 |
Tooth shade resin material |
2 |
|
872.3710 |
Base metal alloy |
2 |
|
872.3750 |
Bracket adhesive resin and tooth conditioner |
2 |
|
872.3760 |
Denture relining, repairing, or rebasing resin |
2 |
|
872.3765 |
Pit and fissure sealant and conditioner |
2 |
|
872.3770 |
Temporary crown and bridge resin |
2 |
|
872.3820 |
Root canal filling resin (other than chloroform use) |
2 |
|
872.3920 |
Porcelain tooth |
2 |
|
Dental x-ray |
872.1800 |
Extraoral source x-ray system |
2 |
872.1810 |
Intraoral source x-ray system |
2 |
|
Dental Implants |
872.4880 |
Intraosseous fixation screw or wires |
2 |
872.3890 |
Endodontic stabilising splint |
2 |
|
Orthodontic |
872.5470 |
Orthodontic plastic bracket |
2 |
EAR/NOSE/THROAT PANEL |
|||
Diagnostic Equipment |
874.1050 |
Audiometer |
2 |
874.1090 |
Auditory impedance tester |
2 |
|
874.1120 |
Electronic noise generator for audiometric testing |
2 |
|
874.1325 |
Electroglottograph |
2 |
|
874.1820 |
Surgical nerve stimulator/locator |
2 |
|
Hearing Aids |
874.3300 |
Hearing aid (for bone-conduction) |
2 |
874.3310 |
Hearing aid calibrator and analysis system |
2 |
|
874.3320 |
Group hearing aid or group auditory trainer |
2 |
|
874.3330 |
Master hearing aid |
2 |
|
Surgical Equipment |
874.4250 |
Ear, nose, and throat electric or pneumatic surgical drill |
1 |
874.4490 |
Argon laser for otology, rhinology, and laryngology |
2 |
|
874.4500 |
ENT microsurgical carbon dioxide laser |
2 |
|
GASTROENTEROLOGY/UROLOGY PANEL |
|||
Endoscope (including angioscopes, laparscopes, ophtalmic endoscopes) |
876.1500 |
Endoscope and accessories |
2 |
876.4300 |
Endoscopic electrosurgical unit and accessories |
2 |
|
Gastroenterology |
876.1725 |
Gastrointestinal motility monitoring system |
1 |
Hemodialysis |
876.5600 |
Sorbent regenerated dialysate delivery system for hemodialysis |
2 |
876.5630 |
Peritoneal dialysis system and accessories |
2 |
|
876.5665 |
Water purification system for hemodialysis |
2 |
|
876.5820 |
Hemodialysis system for accessories |
2 |
|
876.5830 |
Hemodialyser with disposable insert (kiil-type) |
2 |
|
Lithotriptor |
876.4500 |
Mechanical lithotriptor |
2 |
Urology Equipment |
876.1620 |
Urodynamics measurement system |
2 |
876.5320 |
Nonimplanted electrical continence device |
2 |
|
876.5880 |
Isolated kidney perfusion and transport system and accessories |
2 |
|
GENERAL HOSPITAL PANEL |
|||
Infusion Pumps and Systems |
880.2420 |
Electronic monitor for gravity flow infusion systems |
2 |
880.2460 |
Electrically powered spinal fluid pressure monitor |
2 |
|
880.5430 |
Nonelectrically powered fluid injector |
2 |
|
880.5725 |
Infusion pump |
2 |
|
Neonatal Incubators |
880.5400 |
Neonatal incubator |
2 |
880.5410 |
Neonatal transport incubator |
2 |
|
880.5700 |
Neonatal phototherapy unit |
2 |
|
Piston Syringes |
880.5570 |
Hypodermic single lumen needle |
1 |
880.5860 |
Piston syringe (except anti-stick) |
1 |
|
880.6920 |
Syringe needle introducer |
2 |
|
Miscellaneous |
880.2910 |
Clinical electronic thermometer |
2 |
880.2920 |
Clinical mercury thermometer |
2 |
|
880.5100 |
AC-powered adjustable hospital bed |
1 |
|
880.5500 |
AC-powered patient lift |
2 |
|
880.6880 |
Steam Steriliser (greater than 2 cubic feet) |
2 |
|
NEUROLOGY PANEL |
|||
|
882.1020 |
Rigidity analyser |
2 |
882.1610 |
Alpha monitor |
2 |
|
Neuro-Diagnostic |
882.1320 |
Cutaneous electrode |
2 |
882.1340 |
Nasopharyngeal electrode |
2 |
|
882.1350 |
Needle electrode |
2 |
|
882.1400 |
Electroencephalograph |
2 |
|
882.1460 |
Nystagmograph |
2 |
|
882.1480 |
Neurological endoscope |
2 |
|
882.1540 |
Galvanic skin response measurement device |
2 |
|
882.1550 |
Nerve conduction velocity measurement device |
2 |
|
882.1560 |
Skin potential measurement device |
2 |
|
882.1570 |
Powered direct-contact temperature measurement device |
2 |
|
882.1620 |
Intracranial pressure monitoring device |
2 |
|
882.1835 |
Physiological signal amplifier |
2 |
|
882.1845 |
Physiological signal conditioner |
2 |
|
882.1855 |
Electroencephalogram (EEG) telemetry system |
2 |
|
882.5050 |
Biofeedback device |
2 |
|
Echoencephalography |
882.1240 |
Echoencephalograph |
2 |
RPG |
882.4400 |
Radiofrequency lesion generator |
2 |
Neuro Surgery |
none |
Electrode, spinal epidural |
2 |
882.4305 |
Powered compound cranial drills, burrs, trephines and their accessories |
2 |
|
882.4310 |
Powered simple cranial drills, burrs, trephines and accessories |
2 |
|
882.4360 |
Electric cranial drill motor |
2 |
|
882.4370 |
Pneumatic cranial drill motor |
2 |
|
882.4560 |
Sterotaxic instrument |
2 |
|
882.4725 |
Radiofrequency lesion probe |
2 |
|
882.4845 |
Powered rongeur |
2 |
|
882.5500 |
Lesion temperature monitor |
2 |
|
Stimulators |
882.1870 |
Evoked response electrical stimulator |
2 |
882.1880 |
Evoked response mechanical stimulator |
2 |
|
882.1890 |
Evoked response photic stimulator |
2 |
|
882.1900 |
Evoked response auditory stimulator |
2 |
|
882.1950 |
Tremor transducer |
2 |
|
882.5890 |
Transcutaneous electrical nerve stimulator for pain relief |
2 |
|
OBSTETRICS/GYNAECOLOGY PANEL |
|||
Fetal Monitoring |
884.1660 |
Transcervical endoscope (amnioscope) and accessories |
2 |
884.1690 |
Hysteroscope and accessories (for performance standards) |
2 |
|
884.2225 |
Obstetric-gynecologic ultrasonic imager |
2 |
|
884.2600 |
Fetal cardiac monitor |
2 |
|
884.2640 |
Fetal phonocardiographic monitor and accessories |
2 |
|
884.2660 |
Fetal ultrasonic monitor and accessories |
2 |
|
884.2675 |
Fetal scalp circular (spiral) electrode and applicator |
1 |
|
884.2700 |
Intrauterine pressure monitor and accessories |
2 |
|
884.2720 |
External uterine contraction monitor and accessories |
2 |
|
884.2740 |
Perinatal monitoring system and accessories |
2 |
|
884.2960 |
Obstetric ultrasonic transducer and accessories |
2 |
|
Gynecological Surgery Equipment |
884.1720 |
Gynecologic laparoscope and accessories |
2 |
884.4160 |
Unipolar endoscopic coagulator-cutter and accessories |
2 |
|
884.4550 |
Gynecologic surgical laser |
2 |
|
884.4120 |
Gynecologic electrocautery and accessories |
2 |
|
884.5300 |
Condom |
2 |
|
Ophthalm. Implants |
886.3320 |
Eye sphere implant |
2 |
Contact Lens |
886.1385 |
Polymethylmethacrylate (PMMA) diagnostic contact lens |
2 |
886.5916 |
Rigid gas permeable contact lens (daily wear only) |
2 |
|
Diagnostic Equipment |
886.1120 |
Ophthalmic camera |
1 |
886.1220 |
Corneal electrode |
1 |
|
886.1250 |
Euthyscope (AC-powered) |
1 |
|
886.1360 |
Visual field laser instrument |
1 |
|
886.1510 |
Eye movement monitor |
1 |
|
886.1570 |
Ophthalmoscope |
1 |
|
886.1630 |
AC-powered photostimulator |
1 |
|
886.1640 |
Ophthalmic preamplifier |
1 |
|
886.1670 |
Ophthalmic isotope uptake probe |
2 |
|
886.1780 |
Retinoscope (AC-powered device) |
1 |
|
886.1850 |
AC-powered slitlamp biomicroscope |
1 |
|
886.1930 |
Tonometer and accessories |
2 |
|
886.1945 |
Transilluminator (AC-powered device) |
1 |
|
886.3130 |
Ophthalmic conformer |
2 |
|
(Diagnostic/Surgery Equipment) |
886.4670 |
Phacofragmentation System |
2 |
Ophthalm. Implants |
886.3340 |
Extraocular orbital implant |
2 |
886.3800 |
Scleral shell |
2 |
|
Surgical Equipment |
886.5725 |
Infusion pump (performance standards) |
2 |
886.3100 |
Ophthalmic tantalum clip |
2 |
|
886.3300 |
Absorbable implant (scleral buckling method) |
2 |
|
886.4100 |
Radiofrequency electrosurgical cautery apparatus |
2 |
|
886.4115 |
Thermal cautery unit |
2 |
|
886.4150 |
Vitreous aspiration and cutting instrument |
2 |
|
886.4170 |
Cryophthalmic unit |
2 |
|
886.4250 |
Ophthalmic electrolysis unit (AC-powered device) |
1 |
|
886.4335 |
Operating headlamp (AC-powered device) |
1 |
|
886.4390 |
Ophthalmic laser |
2 |
|
886.4392 |
Nd:YAG laser for posterior capsulotomy |
2 |
|
886.4400 |
Electronic metal locator |
1 |
|
886.4440 |
AC-powered magnet |
1 |
|
886.4610 |
Ocular pressure applicator |
2 |
|
886.4690 |
Ophthalmic photocoagulator |
2 |
|
886.4790 |
Ophthalmic sponge |
2 |
|
886.5100 |
Ophthalmic beta radiation source |
2 |
|
none |
Ophthalmoscopes, replacement batteries, hand-held |
1 |
|
ORTHOPEDIC PANEL |
|||
Implants |
888.3010 |
Bone fixation cerclage |
2 |
888.3020 |
Intramedullary fixation rod |
2 |
|
888.3030 |
Single/multiple component metallic bone fixation appliance and accessories |
2 |
|
888.3040 |
Smooth or threaded metallic bone fixation |
2 |
|
888.3050 |
Spinal interlaminal fixation orthosis |
2 |
|
888.3060 |
Spinal intervertebral body fixation orthosis |
2 |
|
Surgical Equipment |
888.1240 |
AC-powered dynamometer |
2 |
888.4580 |
Sonic surgical instrument and accessories/attachments |
2 |
|
none |
Accessories, fixation, spinal interlaminal |
2 |
|
none |
Accessories, fixation, spinal intervertebral body |
2 |
|
none |
Monitor, pressure, intracompartmental |
1 |
|
none |
Orthosis, fixation, spinal intervertebral fusion |
2 |
|
none |
Orthosis, spinal pedicle fixation |
|
|
none |
System, cement removal extraction |
1 |
|
PHYSICAL MEDICINE PANEL |
|||
Diagnostic Equipement |
890.1225 |
Chronaximeter |
2 |
890.1375 |
Diagnostic electromyograph |
2 |
|
890.1385 |
Diagnostic electromyograph needle electrode |
2 |
|
890.1450 |
Powered reflex hammer |
2 |
|
890.1850 |
Diagnostic muscle stimulator |
2 |
|
or (Therapy) |
890.5850 |
Powered muscle stimulator |
2 |
Therapeutic Equipment |
890.5100 |
Immersion hydrobath |
2 |
890.5110 |
Paraffin bath |
2 |
|
890.5500 |
Infrared lamp |
2 |
|
890.5720 |
Water circulating hot or cold pack |
2 |
|
890.5740 |
Powered heating pad |
2 |
|
RADIOLOGY PANEL |
|||
MRI |
892.1000 |
Magnetic resonance diagnostic device |
2 |
Ultrasound Diagnostic |
884.2660 |
Fetal ultrasonic monitor and accessories |
2 |
892.1540 |
Nonfetal ultrasonic monitor |
|
|
892.1560 |
Ultrasonic pulsed echo imaging system |
2 |
|
892.1570 |
Diagnostic ultrasonic transducer |
2 |
|
892.1550 |
Ultrasonic pulsed doppler imaging system |
|
|
Angiographic |
892.1600 |
Angiographic x-ray system |
2 |
Diagnostic X-Ray |
892.1610 |
Diagnostic x-ray beam-limiting device |
2 |
892.1620 |
Cine or spot fluorographic x-ray Camera |
2 |
|
892.1630 |
Electrostatic x-ray imaging system |
2 |
|
892.1650 |
Image-intensified fluoroscopic x-ray system |
2 |
|
892.1670 |
Spot film device |
2 |
|
892.1680 |
Stationary x-ray system |
2 |
|
892.1710 |
Mammographic x-ray system |
2 |
|
892.1720 |
Mobile x-ray system |
2 |
|
892.1740 |
Tomographic x-ray system |
1 |
|
892.1820 |
Pneumoencephalographic chair |
2 |
|
892.1850 |
Radiographic film cassette |
1 |
|
892.1860 |
Radiographic film/cassette changer |
1 |
|
892.1870 |
Radiographic film/cassette changer programmer |
2 |
|
892.1900 |
Automatic radiographic film processor |
2 |
|
892.1980 |
Radiologic table |
1 |
|
CT Scanner |
892.1750 |
Computed tomography x-ray system |
2 |
Radiation Therapy |
892.5050 |
Medical charged-particle radiation therapy system |
2 |
892.5300 |
Medical neutron radiation therapy system |
2 |
|
892.5700 |
Remote controlled radionuclide-applicator system |
2 |
|
892.5710 |
Radiation therapy beam-shaping block |
2 |
|
892.5730 |
Radionuclide brachytherapy source |
2 |
|
892.5750 |
Radionuclide radiation therapy system |
2 |
|
892.5770 |
Powered radiation therapy patient support assembly |
2 |
|
892.5840 |
Radiation therapy stimulation system |
2 |
|
892.5930 |
Therapeutic x-ray tube housing assembly |
1 |
|
Nuclear Medicine |
892.1170 |
Bone densitometer |
2 |
892.1200 |
Emission computed tomography system |
2 |
|
892.1310 |
Nuclear tomography system |
1 |
|
892.1390 |
Radionuclide rebreathing system |
2 |
|
GENERAL/PLASTIC SURGERY PANEL |
|||
Surgical Lamps |
878.4630 |
Ultraviolet lamp for dermatologic disorders |
2 |
890.5500 |
Infrared lamp |
2 |
|
878.4580 |
Surgical lamp |
2 |
|
Electrosurgical Cutting Equipment |
878.4810 |
Laser surgical instrument for use in general and plastic surgery and in dermatology |
2 |
878.4400 |
Electrosurgical cutting and coagulation device and accessories |
2 |
|
Miscellaneous |
878.4780 |
Powered suction pump |
2 |
Appendix 3
Authorities responsible for designating conformity assessment bodies
EC access to the US market |
US access to the EC market |
||||||||||||||||||||||||||||||
|
Food and Drug Administration (FDA) |
Appendix 4
Conformity assessment bodies
EC access to the US market |
US access to the EC market |
Conformity assessment bodies located in the EC shall be designated by the Authorities identified in Appendix 3. |
Conformity assessment bodies located in the US shall be designated by the Authorities identified in Appendix 3. |
(to be provided by the EC) |
(to be provided by the US) |