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RapidFor™ SARS-CoV-2 + FLU A/B + RSV + ADV + hMPV Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref VMD146Model VMD146SCRef ICA2508Model 20 Tests/kit
Identity
- Trade Name
- RapidFor™ SARS-CoV-2 + FLU A/B + RSV + ADV + hMPV Test Kit EUDAMED
- Device Name
- SARS-CoV-2 + FLU A/B + RSV + ADV + hMPV Test Kit EUDAMEDSARS-CoV-2/Flu A/Flu B/RSV/ADV/HMPV Antigen Rapid Test Kit (Immunochromatographic Assay) EUDAMED
- Model / Reference
- VMD146SC EUDAMEDVMD146 EUDAMED20 Tests/kit EUDAMEDICA2508 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684595036570 EUDAMED06974541565615 EUDAMED
- Basic UDI-DI
- B-08684595036570 EUDAMEDB-06974541565615 EUDAMED
- EMDN Code
- W0105090699 OTHER MULTIPLE PATHOGENS - RT & POC EUDAMEDW0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMEDFrance 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
EUDAMEDEUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMEDEUDAMED
Surgical Instrument
No
EUDAMED
RapidFor™ SARS-CoV-2 + FLU A/B + RSV + ADV + hMPV 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-08684595036570 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Vitrosens Biotechnology Inc.
- EUDAMED SRN
- TR-MF-000026452
Sources (2)
- EUDAMED b453ded3-5359-4fc3-9741-c0fb1ffb8086 61 fields · synced Aug 1, 2026
- EUDAMED a9b29df1-95e8-44b3-bfb5-0a7608f63ac5 61 fields · synced Jul 9, 2026