Identity
- Trade Name
- Chemiluminescence Immunoassay Analyzer EUDAMED
- Device Name
- Chemiluminescence Immunoassay Analyzer EUDAMED
- Model / Reference
- SZY-CL1000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974986813654 EUDAMED
- Basic UDI-DI
- 697498681SZYYQ02XJ EUDAMED
- Direct Marketing DI
- 06974986813654 EUDAMED
- EMDN Code
- W02079099 VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - OTHER 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
Chemiluminescence Immunoassay Analyzer by Wuhan Life Origin Biotech Joint Stock 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 | 697498681SZYYQ02XJ | Class A | Active |
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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 e1844979-6274-4d72-ac31-157ea02bac6b 61 fields · synced Oct 6, 2026