Identity
- Trade Name
- CK-MB EUDAMEDCK EUDAMED
- Device Name
- CK-MB EUDAMEDCK EUDAMED
- Model / Reference
- 0018482200 EUDAMED0018164640 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08426950451808 EUDAMED08426951394050 EUDAMED
- Basic UDI-DI
- 842695045180884 EUDAMED84269513940508Y EUDAMED
- Direct Marketing DI
- 08426950451808 EUDAMED08426951394050 EUDAMED
- EMDN Code
- W01010114 CREATINE KINASE - MB ACTIVITY (CC) EUDAMEDW01010113 CREATINE KINASE - TOTAL EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMEDEUDAMED
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 by Instrumentation Laboratory SpA — 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 | 842695045180884 | Class C | Active |
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Manufacturer
- Manufacturer
- Instrumentation Laboratory SpA
- EUDAMED SRN
- IT-MF-000009277
Sources (2)
- EUDAMED 040d295f-0e0f-4776-8cf6-ddee4ce7c510 61 fields · synced Sep 17, 2026
- EUDAMED c6eefcf6-aac4-46bc-9c7e-a125c95b34bd 61 fields · synced May 18, 2026