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CK-MB CLIA Microparticles
EUDAMEDClass C (EU MDR)
Ref CMH0305Model AutoLumo analyzerRef CMH0310Ref CMH0303
Identity
- Trade Name
- CK-MB CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMH0305 EUDAMEDCMH0310 EUDAMEDCMH0303 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359548014 EUDAMED06942359511407 EUDAMED06942359547994 EUDAMED
- Basic UDI-DI
- 697015090000037H7 EUDAMED
- EMDN Code
- W01021311 CREATINE KINASE - MB MASS (IC) EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
CK-MB CLIA Microparticles by Autobio Diagnostics Co., Ltd. — Class C — 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 | 697015090000037H7 | Class C | Active |
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Manufacturer
- Manufacturer
- Autobio Diagnostics Co., Ltd.
- EUDAMED SRN
- CN-MF-000003348
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (3)
- EUDAMED e106198a-650b-4e6e-8ddc-fb15efcd9e75 61 fields · synced Jul 8, 2026
- EUDAMED 46e8f737-b523-461e-a7c6-f752e98adbc2 61 fields · synced May 18, 2026
- EUDAMED 648a0069-e0fe-4e43-afef-a66f56f55d4d 61 fields · synced May 18, 2026