Identity
- Trade Name
- HUBI DIA EUDAMED
- Device Name
- HUBI DIA EUDAMED
- Model / Reference
- AHD-8001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800210900051 EUDAMED
- Basic UDI-DI
- 8800210900058G EUDAMED
- EMDN Code
- W0101060499 MULTIPLE PARAMETERS POC - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Iceland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
Yes
EUDAMED
Hubi Dia by CareforU.Co.Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 8800210900058G | Class A | 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 ed073b95-6375-4861-8582-d7d877ce876b 61 fields · synced Oct 6, 2026