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Automated Chemiluminescence Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref Lumimate 300A
Identity
- Trade Name
- Automated Chemiluminescence Immunoassay Analyzer EUDAMED
- Device Name
- Automated Chemiluminescence Immunoassay Analyzer EUDAMED
- Model / Reference
- Lumimate 300A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974621211579 EUDAMED
- Basic UDI-DI
- 697462121LumimateZQ EUDAMED
- Direct Marketing DI
- 06974621211579 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
Automated 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 | 697462121LumimateZQ | 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 7b962a28-855b-4fa7-8b92-4ad930405f37 61 fields · synced Jul 17, 2026