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Fully-Automatic Chemiluminescence Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref Wan200+ SModel Wan200+
Identity
- Device Name
- Fully-Automatic Chemiluminescence Immunoassay Analyzer EUDAMED
- Model / Reference
- Wan200+ EUDAMEDWan200+ S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973597100085 EUDAMED
- Basic UDI-DI
- 697359710Wan200+GK EUDAMED
- Direct Marketing DI
- 06973597100085 EUDAMED
- EMDN Code
- W02010299 IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A 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
Fully-Automatic Chemiluminescence Immunoassay Analyzer by Xiamen United Medical Instruments Co., Ltd. — Class A — IVDR — listed in EUDAMED
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 | 697359710Wan200+GK | Class A | Active |
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Manufacturer
- Manufacturer
- Xiamen United Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000028165
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 1b2651ab-ffa6-43ae-99d8-7906386ec95f 61 fields · synced Jun 17, 2026