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Ck
EUDAMEDClass C (EU MDR)
Ref 1415-0092Ref 1419-0090Ref 1415-0090Ref 1418-0097Ref 1516-0090
Identity
- Trade Name
- CK EUDAMED
- Device Name
- CK EUDAMED
- Model / Reference
- 1415-0092 EUDAMED1419-0090 EUDAMED1415-0090 EUDAMED1418-0097 EUDAMED1516-0090 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05204309173709 EUDAMED05204309161195 EUDAMED05204309167272 EUDAMED05204309031313 EUDAMED05204309175130 EUDAMED
- Basic UDI-DI
- 5204309000014NM EUDAMED
- EMDN Code
- W01010113 CREATINE KINASE - TOTAL EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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 by Medicon Hellas SA — 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 | 5204309000014NM | Class C | Active |
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Manufacturer
- Manufacturer
- Medicon Hellas SA
- EUDAMED SRN
- GR-MF-000013625
Sources (5)
- EUDAMED ff9a9071-f282-41a2-b2ab-4812bfe25ede 61 fields · synced Aug 3, 2026
- EUDAMED 2db1c8dc-b4bd-4b57-88c5-f5749598ebce 61 fields · synced May 17, 2026
- EUDAMED 0ff8abea-9d9f-4182-9592-c1e429a9c379 61 fields · synced May 18, 2026
- EUDAMED 693af2a8-ec7f-4384-ba03-91b4281b30ef 61 fields · synced May 18, 2026
- EUDAMED d4589ee3-9295-4156-93c6-6673e8b2267b 61 fields · synced May 19, 2026