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Fluorescence Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref 18-05-0027Model FIS-1000Ref 29-01-0002
Identity
- Trade Name
- Fluorescence Immunoassay Analyzer EUDAMED
- Device Name
- Fluorescence Immunoassay Analyzer EUDAMED
- Model / Reference
- FIS-1000 EUDAMED18-05-0027 EUDAMED29-01-0002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974674892107 EUDAMED06974674896112 EUDAMED
- Basic UDI-DI
- 697467489000389R EUDAMED
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMEDSpain 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
Fluorescence Immunoassay Analyzer by Shenzhen Zijian 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 | 697467489000389R | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Zijian Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000022829
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 69adecbd-5da4-4ff8-8699-ef7924742500 61 fields · synced Oct 6, 2026
- EUDAMED 9258c354-2005-4253-a0fe-ffdee1502dfb 61 fields · synced May 18, 2026