Identity
- Trade Name
- SMALL DRY FLUORESCENCE IMMUNOASSAY ANALYZER EUDAMED
- Device Name
- SMALL DRY FLUORESCENCE IMMUNOASSAY ANALYZER EUDAMED
- Model / Reference
- FIC-H0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978502842074 EUDAMED
- Basic UDI-DI
- 697850284SZYYQ04NK EUDAMED
- Direct Marketing DI
- 06978502842074 EUDAMED
- EMDN Code
- W0201020101,W02010299 EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Small Dry Fluorescence Immunoassay Analyzer by Wuhan Life Origin Biotech Joint Stock Co., Ltd. — Class A — IVDR — listed in EUDAMED
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 | 697850284SZYYQ04NK | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wuhan Life Origin Biotech Joint Stock Co., Ltd.
- EUDAMED SRN
- CN-MF-000027340
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 39dfc008-7437-45ca-80e3-95622861c6f3 61 fields · synced Jun 18, 2026