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Rapid Anti-HCV Test
EUDAMEDClass IVD Annex II List A (EU MDR)
Ref ITP01153-TC40Ref ITP01153-TC10Ref ITP01152-TC25
Identity
- Device Name
- Rapid Anti-HCV Test EUDAMED
- Model / Reference
- ITP01153-TC40 EUDAMEDITP01153-TC10 EUDAMEDITP01152-TC25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936155804313 EUDAMED06936155804306 EUDAMED06936155804283 EUDAMED
- Basic UDI-DI
- B-06936155804313 EUDAMEDB-06936155804306 EUDAMEDB-06936155804283 EUDAMED
- EMDN Code
- W0105020303 HCV ANTIBODY (TOTAL) EUDAMED
Classification
- Device Class
- Class IVD Annex II List A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Rapid Anti-HCV Test by InTec PRODUCTS, 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-06936155804313 | Class IVD Annex II List A | Active |
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Manufacturer
- Manufacturer
- InTec PRODUCTS, INC.
- EUDAMED SRN
- CN-MF-000023625
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (3)
- EUDAMED 203051eb-95c6-4c91-abd9-afa0e0fc7f19 61 fields · synced Jul 29, 2026
- EUDAMED 2c640c3f-d3e6-4a8f-82f0-99b870143b59 61 fields · synced May 18, 2026
- EUDAMED 10c569d1-d1a7-4d8b-aa65-c87b543ba098 61 fields · synced May 18, 2026