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Fluorescence Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref QDS-300CRef QDS-300ARef QDS-300B
Identity
- Trade Name
- Fluorescence Immunoassay Analyzer EUDAMED
- Device Name
- Fluorescence Immunoassay Analyzer EUDAMED
- Model / Reference
- QDS-300C EUDAMEDQDS-300A EUDAMEDQDS-300B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921963719683 EUDAMED06921963719669 EUDAMED06921963719676 EUDAMED
- Basic UDI-DI
- 692196371965K7 EUDAMED
- Direct Marketing DI
- 06921963719683 EUDAMED06921963719669 EUDAMED06921963719676 EUDAMED
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER 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
Fluorescence Immunoassay Analyzer by Xiamen Boson 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 | 692196371965K7 | Class A | Active |
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Manufacturer
- Manufacturer
- Xiamen Boson Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000001096
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (3)
- EUDAMED 3881d9d3-01a9-47d3-bfc9-3daebba68f39 61 fields · synced Aug 3, 2026
- EUDAMED de3272df-3ebc-447a-aafa-eb9a703ff6db 61 fields · synced May 18, 2026
- EUDAMED 4ac85d9b-e2d4-4d62-946e-78a600b8fbdc 61 fields · synced May 18, 2026