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careSTART™ Hb Biosensor Control
EUDAMEDClass IVD General (EU MDR)
Ref HCA-N05082
Identity
- Device Name
- careSTART™ Hb Biosensor Control EUDAMED
- Model / Reference
- HCA-N05082 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809446081589 EUDAMED
- Basic UDI-DI
- B-08809446081589 EUDAMED
- EMDN Code
- W010106010801 BLOOD TEST STRIPS CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
careSTART™ Hb Biosensor Control 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-08809446081589 | 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 d7ce52fc-8aea-49ea-b329-226ddba89900 61 fields · synced Jun 18, 2026