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Automated Chemiluminescence Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref CK-KR-CLIA-008Model Kaeser 8800
Identity
- Device Name
- Automated Chemiluminescence Immunoassay Analyzer EUDAMED
- Model / Reference
- Kaeser 8800 EUDAMEDCK-KR-CLIA-008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926980316945 EUDAMED
- Basic UDI-DI
- 69269803YQKaeser8800XH EUDAMED
- EMDN Code
- W0201020104 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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
Automated Chemiluminescence Immunoassay Analyzer by Guangzhou Kangrun 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 | 69269803YQKaeser8800XH | Class A | Active |
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Manufacturer
- Manufacturer
- Guangzhou Kangrun Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000032267
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED 5b1e6769-06ab-49c3-9153-eaf094f7039e 61 fields · synced Jul 31, 2026