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RapidFor™ AFP Rapid Test Kit (FIA)
EUDAMEDClass IVD General (EU MDR)
Ref VMPO51Ref VMD44
Identity
- Trade Name
- RapidFor™ AFP Rapid Test Kit (FIA) EUDAMEDRapidFor™ AFP Rapid Test Kit EUDAMED
- Device Name
- AFP Rapid Test Kit (FIA) EUDAMEDAFP Rapid Test Kit EUDAMED
- Model / Reference
- VMPO51 EUDAMEDVMD44 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683548250896 EUDAMED08683347941506 EUDAMED
- Basic UDI-DI
- B-08683548250896 EUDAMEDB-08683347941506 EUDAMED
- EMDN Code
- W0102039001 ALPHAFETOPROTEIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Surgical Instrument
No
EUDAMED
RapidFor™ AFP Rapid Test Kit (FIA) by Vitrosens Biotechnology 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-08683548250896 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Vitrosens Biotechnology Inc.
- EUDAMED SRN
- TR-MF-000026452
Sources (2)
- EUDAMED 77dd6217-7f5d-4773-a8c4-d781b75bcca2 61 fields · synced Oct 6, 2026
- EUDAMED 738bdd64-4e52-4999-a691-6e6a315f1ed7 61 fields · synced May 17, 2026