← Back to catalogue
RapidFor™ Strep A Rapid Test Kit (FIA)
EUDAMEDClass IVD General (EU MDR)
Ref VMPO61TDModel VMPO61
Identity
- Trade Name
- RapidFor™ Strep A Rapid Test Kit (FIA) EUDAMED
- Device Name
- Strep A Rapid Test Kit (FIA) EUDAMED
- Model / Reference
- VMPO61 EUDAMEDVMPO61TD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684595036709 EUDAMED
- Basic UDI-DI
- B-08684595036709 EUDAMED
- EMDN Code
- W0105090103 STREP. A - 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
Yes
EUDAMED
RapidFor™ Strep A 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-08684595036709 | 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 (1)
- EUDAMED 9170173b-cdd7-4d26-b26a-bdada383bb93 61 fields · synced Oct 6, 2026