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RapidFor™ SARS-CoV-2/FLU A & B Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref VSCD08Model VSCD08SCRef VSCD10Model VSCD10SC
Identity
- Trade Name
- RapidFor™ SARS-CoV-2/FLU A & B Test Kit EUDAMEDRapidFor™ SARS-CoV-2 + FLU A/B Test Kit EUDAMED
- Device Name
- SARS-CoV-2/FLU A & B Test Kit EUDAMEDRapidFor™SARS-CoV-2 + FLU A/B Test Kit EUDAMED
- Model / Reference
- VSCD08SC EUDAMEDVSCD08 EUDAMEDVSCD10SC EUDAMEDVSCD10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683548252142 EUDAMED08683347941728 EUDAMED
- Basic UDI-DI
- B-08683548252142 EUDAMEDB-08683347941728 EUDAMED
- EMDN Code
- W0105090601 CORONAVIRUS / INFLUENZA - 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
No
EUDAMED
RapidFor™ SARS-CoV-2/FLU A & B 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-08683548252142 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Vitrosens Biotechnology Inc.
- EUDAMED SRN
- TR-MF-000026452
Sources (2)
- EUDAMED b50fa26b-5ed3-448a-a02e-06032ac78b85 61 fields · synced Oct 6, 2026
- EUDAMED a912c1fc-4a74-44e6-8521-7d6292594c19 61 fields · synced May 19, 2026