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Chemiluminescence Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref CLIA-mateModel CLIA-mate Series
Identity
- Trade Name
- Chemiluminescence Immunoassay Analyzer EUDAMED
- Device Name
- Chemiluminescence Immunoassay Analyzer EUDAMED
- Model / Reference
- CLIA-mate Series EUDAMEDCLIA-mate EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974621212118 EUDAMED
- Basic UDI-DI
- 697462121CLIAmateGJ EUDAMED
- Direct Marketing DI
- 06974621212118 EUDAMED
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 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
Chemiluminescence Immunoassay Analyzer by Aikang MedTech 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 | 697462121CLIAmateGJ | Class A | Active |
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Manufacturer
- Manufacturer
- Aikang MedTech Co., Ltd
- EUDAMED SRN
- CN-MF-000027272
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED d93ab8ab-a5f2-4bd8-ac17-1e967ce84593 61 fields · synced Jul 31, 2026