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RapidFor™ Pregnancy Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref VMD60CModel VMD60C25Ref VMD60SModel VMD60S50Ref VMD60MModel VMD60M01
Identity
- Trade Name
- RapidFor™ Pregnancy Test Kit EUDAMED
- Device Name
- Pregnancy Test Kit EUDAMED
- Model / Reference
- VMD60C25 EUDAMEDVMD60C EUDAMEDVMD60S50 EUDAMEDVMD60S EUDAMEDVMD60M01 EUDAMEDVMD60M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684595036525 EUDAMED08684595036532 EUDAMED08684595036518 EUDAMED
- Basic UDI-DI
- B-08684595036525 EUDAMEDB-08684595036532 EUDAMEDB-08684595036518 EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC 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™ Pregnancy Test Kit 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-08684595036525 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Vitrosens Biotechnology Inc.
- EUDAMED SRN
- TR-MF-000026452
Sources (3)
- EUDAMED dc78267e-18af-4a92-9de0-31b507bb4670 61 fields · synced Oct 6, 2026
- EUDAMED 27a9bc5a-27af-499b-9074-35a8f2976b32 61 fields · synced May 17, 2026
- EUDAMED 29b981d0-b91a-4eeb-9866-9f0304dbc636 61 fields · synced May 18, 2026