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WellFor Strep A v2.0 Test Kit
EUDAMEDClass IVD General (EU MDR)
Ref VMD150STModel VMD150ST01
Identity
- Trade Name
- WellFor Strep A v2.0 Test Kit EUDAMED
- Device Name
- Strep A v2.0 Test Kit EUDAMED
- Model / Reference
- VMD150ST01 EUDAMEDVMD150ST EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684595039885 EUDAMED
- Basic UDI-DI
- B-08684595039885 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
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Surgical Instrument
No
EUDAMED
WellFor Strep A v2.0 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-08684595039885 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Vitrosens Biotechnology Inc.
- EUDAMED SRN
- TR-MF-000026452
Sources (1)
- EUDAMED 857781cb-be70-4398-bec4-bb909297684c 61 fields · synced Jul 18, 2026