← Back to catalogue
RapidFor™ Myo + CK-MB + Troponin I Combo Rapid Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref VMD55
Identity
- Trade Name
- RapidFor™ Myo + CK-MB + Troponin I Combo Rapid Test Kit EUDAMED
- Device Name
- Myo + CK-MB + Troponin I Combo Rapid Test Kit EUDAMED
- Model / Reference
- VMD55 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683347941612 EUDAMED
- Basic UDI-DI
- B-08683347941612 EUDAMED
- EMDN Code
- W0102160702,W0102160703,W0102160799 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™ Myo + CK-MB + Troponin I Combo Rapid Test Kit by Vitrosens Biotechnology Inc. — Class IVD General — IVDD — listed in EUDAMED
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-08683347941612 | 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 509eb7fa-062a-4553-b1aa-45369665bf79 61 fields · synced Oct 6, 2026