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Full-Automatic Chemiluminescence Immunoassay System
EUDAMEDClass A (EU MDR)
Ref FACIS-I
Identity
- Device Name
- Full-Automatic Chemiluminescence Immunoassay System EUDAMED
- Model / Reference
- FACIS-I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970514080710 EUDAMED
- Basic UDI-DI
- 697051408FACISICZ EUDAMED
- Direct Marketing DI
- 06970514080710 EUDAMED
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
Full-Automatic Chemiluminescence Immunoassay System by Genobio Pharmaceutical 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 | 697051408FACISICZ | Class A | Active |
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Manufacturer
- Manufacturer
- Genobio Pharmaceutical Co., Ltd.
- EUDAMED SRN
- CN-MF-000027997
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 8277b8f4-cb7a-45ff-b435-11ca3c422054 61 fields · synced Jul 25, 2026