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One Step α-Fetoprotein (AFP) Test
EUDAMEDClass IVD General (EU MDR)
Ref ITP12002-TC40Model ITP12002
Identity
- Trade Name
- One Step α-Fetoprotein (AFP) Test EUDAMED
- Device Name
- One Step α-Fetoprotein (AFP) Test EUDAMED
- Model / Reference
- ITP12002 EUDAMEDITP12002-TC40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936155803477 EUDAMED
- Basic UDI-DI
- B-06936155803477 EUDAMED
- EMDN Code
- W0102160199 SPECIFIC PROTEINS RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
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
One Step α-Fetoprotein (AFP) Test by InTec PRODUCTS, INC. — Class IVD General — 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-06936155803477 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- InTec PRODUCTS, INC.
- EUDAMED SRN
- CN-MF-000023625
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 66f0a442-a30d-4197-b9c6-e6ea76fd438d 61 fields · synced Jun 19, 2026