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Automatic Fluorescence Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref QD-S2000
Identity
- Trade Name
- Automatic Fluorescence Immunoassay Analyzer EUDAMED
- Device Name
- Automatic Fluorescence Immunoassay Analyzer EUDAMED
- Model / Reference
- QD-S2000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973315739580 EUDAMED
- Basic UDI-DI
- 6973315739580BG EUDAMED
- Direct Marketing DI
- 06973315739580 EUDAMED
- EMDN Code
- W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Automatic Fluorescence Immunoassay Analyzer by Nanjing Vazyme Medical Technology 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 | 6973315739580BG | Class A | Active |
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Manufacturer
- Manufacturer
- Nanjing Vazyme Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000031032
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED de763c82-5437-4d3c-a607-89589a60e762 61 fields · synced Oct 6, 2026
- EUDAMED ed2f7bb7-42fd-4c72-9bc9-e68862d206fe 61 fields · synced Jul 26, 2026