Identity
- Trade Name
- RapidFor™ PCT Rapid Test Kit EUDAMED
- Device Name
- PCT Rapid Test Kit EUDAMED
- Model / Reference
- VMD47 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683347941537 EUDAMED08684595030837 EUDAMED
- Basic UDI-DI
- B-08683347941537 EUDAMEDB-08684595030837 EUDAMED
- EMDN Code
- W0102069013 PROCALCITONIN 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
Yes
EUDAMEDEUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Surgical Instrument
No
EUDAMED
RapidFor™ PCT Rapid 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-08683347941537 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vitrosens Biotechnology Inc.
- EUDAMED SRN
- TR-MF-000026452
Sources (2)
- EUDAMED 11010914-4abc-48b1-a7ac-fff604c1d516 61 fields · synced Oct 6, 2026
- EUDAMED c0d8fdf6-d9a6-4490-b30a-a29c0bceff7e 61 fields · synced May 17, 2026