Identity
- Trade Name
- CK-MB SL EUDAMED
- Device Name
- CK-MB SL EUDAMED
- Model / Reference
- CMSL-0410 EUDAMEDCMSL-6255 EUDAMEDCMSL-5405 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701700819325 EUDAMED03701700819318 EUDAMED
- Basic UDI-DI
- 37017008CMSL009T EUDAMED
- EMDN Code
- W01010114 CREATINE KINASE - MB ACTIVITY (CC) EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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 Sl by Vitalscientific — Class B — 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 | 37017008CMSL009T | Class B | Active |
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Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
Sources (2)
- EUDAMED 275a7a02-25f9-4f98-832b-64ad5022bc47 61 fields · synced Jul 23, 2026
- EUDAMED db8af4df-b3e5-4a2c-9a07-a83b6ed629ce 61 fields · synced May 19, 2026