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careSTART™ G6PD Biosensor Control Level II
EUDAMEDClass IVD General (EU MDR)
Ref BGT-N05082
Identity
- Device Name
- careSTART™ G6PD Biosensor Control Level II EUDAMED
- Model / Reference
- BGT-N05082 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809446080704 EUDAMED
- Basic UDI-DI
- B-08809446080704 EUDAMED
- EMDN Code
- W0101050201 ENZYME CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
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
careSTART™ G6PD Biosensor Control Level II by Wells Bio, 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-08809446080704 | Class IVD General | 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 e48f2913-f72e-44eb-ab3d-a7a0d9db8db9 61 fields · synced Jul 28, 2026