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Automated CLEIA system
EUDAMEDClass A (EU MDR)
Ref 101Model Professional testing
Identity
- Trade Name
- Automated CLEIA system EUDAMED
- Device Name
- Automated CLEIA system EUDAMED
- Model / Reference
- Professional testing EUDAMED101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975292640019 EUDAMED
- Basic UDI-DI
- 697529264001MQ EUDAMED
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Automated CLEIA system by Chengdu Illumaxbio Technology 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 | 697529264001MQ | Class A | Active |
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Manufacturer
- Manufacturer
- Chengdu Illumaxbio Technology Co., LTD
- EUDAMED SRN
- CN-MF-000026407
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 45144467-fa3d-44a5-bd3e-9f3d97b0474e 61 fields · synced Jun 19, 2026