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Artron HlV, HBsAg & HCV Combo Test
EUDAMEDClass IVD Annex II List A (EU MDR)
Ref A02-20-222Model Cassette
Identity
- Trade Name
- Artron HlV, HBsAg & HCV Combo Test EUDAMED
- Device Name
- HlV, HBsAg & HCV Combo Test EUDAMED
- Model / Reference
- Cassette EUDAMEDA02-20-222 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00628347561062 EUDAMED
- Basic UDI-DI
- B-00628347561062 EUDAMED
- EMDN Code
- W0105090201,W0105090202,W0105090302 EUDAMED
Classification
- Device Class
- Class IVD Annex II List A 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
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Artron HlV, HBsAg & HCV Combo Test by Artron Laboratories Inc. — Class IVD Annex II List A — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00628347561062 | 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 (1)
- EUDAMED b75bc7a2-efd9-48d9-a120-9d1f27003953 61 fields · synced Jul 14, 2026