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Artron Hepatitis C Virus (HCV) Antibody Test
EUDAMEDClass IVD Annex II List A (EU MDR)
Ref A02-06-222Model cassetteRef A02-06-322P25Model Cassette
Identity
- Trade Name
- Artron Hepatitis C Virus (HCV) Antibody Test EUDAMED
- Device Name
- Hepatitis C Virus (HCV) Antibody Test EUDAMED
- Model / Reference
- cassette EUDAMEDA02-06-222 EUDAMEDA02-06-322P25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00628347560973 EUDAMED00628347560980 EUDAMED
- Basic UDI-DI
- B-00628347560973 EUDAMED62834756AL0206026S EUDAMED
- EMDN Code
- W0105090202 HCV ANTIBODY -RT & POC EUDAMED
Classification
- Device Class
- Class IVD Annex II List A EUDAMEDClass D EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMEDEUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Artron Hepatitis C Virus (HCV) Antibody Test by Artron Laboratories Inc. — Class IVD Annex II List A — IVDR, IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-00628347560973 | Class IVD Annex II List A | Active |
| EUDAMED | European Union | CE/IVDD | B-00628347560973 | Class IVD Annex II List A | Active |
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Manufacturer
- Manufacturer
- Artron Laboratories Inc.
- EUDAMED SRN
- CA-MF-000028974
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 4bfe92dc-65de-447d-b2e6-82a4eb28217a 61 fields · synced Jul 24, 2026
- EUDAMED ba092f3d-add0-403d-be20-5906f954dafc 61 fields · synced Jul 21, 2026