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Dry Fluorescence Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref 9922Model 3000plus
Identity
- Trade Name
- Dry Fluorescence Immunoassay Analyzer EUDAMED
- Device Name
- Dry Fluorescence Immunoassay Analyzer EUDAMED
- Model / Reference
- 3000plus EUDAMED9922 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977565589926 EUDAMED
- Basic UDI-DI
- 6977565589952 EUDAMED
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- France 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
Yes
EUDAMED
Dry Fluorescence Immunoassay Analyzer by Coei 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 | 6977565589952 | Class A | Active |
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Manufacturer
- Manufacturer
- Coei Biotech Co.Ltd.
- EUDAMED SRN
- CN-MF-000049509
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 96faa17c-35e1-47f7-b397-ec2e8a3da891 61 fields · synced Jun 18, 2026