Identity
- Trade Name
- Finecare EUDAMED
- Device Name
- Finecare™ FIA Meter X1 EUDAMED
- Model / Reference
- FS-1000 EUDAMEDW910 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933289822817 EUDAMED
- Basic UDI-DI
- 69332898CE2281FJ EUDAMED
- Direct Marketing DI
- 06933289822817 EUDAMED
- EMDN Code
- W02010299 IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Finecare by Guangzhou Wondfo Biotech 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 | 69332898CE2281FJ | Class A | Active |
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Manufacturer
- Manufacturer
- Guangzhou Wondfo Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000000689
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 1f9b1633-7eef-4b7c-bb8f-9e3e1bd871f0 61 fields · synced Jun 19, 2026