Identity
- Trade Name
- HUBI A1c EUDAMED
- Device Name
- HUBI DIA EUDAMED
- Model / Reference
- CFU-D1 EUDAMEDAHA1C-8010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-8800210900068V9 EUDAMED
- Basic UDI-DI
- B-8800210900068V9 EUDAMED
- EMDN Code
- W0101060107 HBA1C TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Iceland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
HUBI A1c by CareforU.Co.Ltd — 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-8800210900068V9 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- CareforU.Co.Ltd
- EUDAMED SRN
- KR-MF-000031539
- Authorised Representative
- Meridius Medical Europe Limited IE-AR-000004258
Sources (1)
- EUDAMED cd2ca9e7-1c71-4746-88c4-a8cc1e9fc5fe 61 fields · synced Oct 6, 2026