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careGENE™ STD-12 detection kit
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref MST-N10082
Identity
- Device Name
- careGENE™ STD-12 detection kit EUDAMED
- Model / Reference
- MST-N10082 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809446080636 EUDAMED
- Basic UDI-DI
- B-08809446080636 EUDAMED
- EMDN Code
- W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
careGENE™ STD-12 detection kit by Wells Bio, Inc. — Class IVD Annex II List B — 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-08809446080636 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Wells Bio, Inc.
- EUDAMED SRN
- KR-MF-000031789
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 521d5b89-93e3-4195-9bd5-13947dc14b17 61 fields · synced Jul 27, 2026