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RapidFor™ hscTnI Rapid Test Kit (FIA)
EUDAMEDClass IVD General (EU MDR)
Ref VMPO87EPModel VMPO87
Identity
- Trade Name
- RapidFor™ hscTnI Rapid Test Kit (FIA) EUDAMED
- Device Name
- hscTnI Rapid Test Kit (FIA) EUDAMED
- Model / Reference
- VMPO87 EUDAMEDVMPO87EP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684595039038 EUDAMED08683548258182 EUDAMED
- Basic UDI-DI
- B-08684595039038 EUDAMEDB-08683548258182 EUDAMED
- EMDN Code
- W0102160703 TROPONIN I/T - 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
No
EUDAMEDEUDAMED
Surgical Instrument
Yes
EUDAMEDEUDAMED
RapidFor™ hscTnI 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-08684595039038 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Vitrosens Biotechnology Inc.
- EUDAMED SRN
- TR-MF-000026452
Sources (2)
- EUDAMED 1991d83b-ece3-4893-904c-25db3a9b9e2a 61 fields · synced Oct 6, 2026
- EUDAMED e7cea4fd-0062-4838-864a-99fe9acbc88c 61 fields · synced May 16, 2026