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Automatic Chemiluminescence Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref BKI6400
Identity
- Trade Name
- Automatic Chemiluminescence Immunoassay Analyzer EUDAMED
- Device Name
- Automatic Chemiluminescence Immunoassay Analyzer EUDAMED
- Model / Reference
- BKI6400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974969982681 EUDAMED
- Basic UDI-DI
- 697496998ZD002YF EUDAMED
- EMDN Code
- W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 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 Chemiluminescence Immunoassay Analyzer by Biobase Diagnostic Technology (Shandong) 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 | 697496998ZD002YF | Class A | Active |
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Manufacturer
- Manufacturer
- Biobase Diagnostic Technology (Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025964
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 4b63a6d3-47d6-4307-bd89-0c9bd2009a1a 61 fields · synced Jul 24, 2026