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Chemiluminescence Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref PG1001Model C5000
Identity
- Trade Name
- Chemiluminescence Immunoassay Analyzer EUDAMED
- Device Name
- Chemiluminescence Immunoassay Analyzer EUDAMED
- Model / Reference
- C5000 EUDAMEDPG1001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974524061516 EUDAMED
- Basic UDI-DI
- 697452406C50006A EUDAMED
- Direct Marketing DI
- 06974524061516 EUDAMED
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Chemiluminescence Immunoassay Analyzer by Nanjing Poclight Biotechnology 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 | 697452406C50006A | Class A | Active |
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Manufacturer
- Manufacturer
- Nanjing Poclight Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000039609
- Authorised Representative
- HUMISS TRADING S. L. ES-AR-000040177
Sources (1)
- EUDAMED 9ccab3d0-16aa-408d-b070-0b190cc36a10 61 fields · synced Jul 8, 2026