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Creatinine
EUDAMEDClass C (EU MDR)
Ref 1419-0032Ref 1417-0037Ref 1415-0037Ref 1516-0030Ref 1417-0039Ref 1419-0030Ref 1415-0039Ref 1419-0038Ref 1418-0037
Identity
- Trade Name
- CREATININE EUDAMEDCREATININE ENZ EUDAMED
- Device Name
- CREATININE EUDAMEDCREATININE ENZ EUDAMED
- Model / Reference
- 1419-0032 EUDAMED1417-0037 EUDAMED1415-0037 EUDAMED1516-0030 EUDAMED1417-0039 EUDAMED1419-0030 EUDAMED1415-0039 EUDAMED1419-0038 EUDAMED1418-0037 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05204309163250 EUDAMED05204309136681 EUDAMED05204309167791 EUDAMED05204309175253 EUDAMED05204309136698 EUDAMED05204309122875 EUDAMED05204309167609 EUDAMED05204309123414 EUDAMED05204309041053 EUDAMED
- Basic UDI-DI
- 5204309000016NR EUDAMED5204309000017NT EUDAMED
- Direct Marketing DI
- 05204309163250 EUDAMED05204309136681 EUDAMED05204309167791 EUDAMED05204309122875 EUDAMED05204309041053 EUDAMED
- EMDN Code
- W01010207 CREATININE 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
Creatinine 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 | 5204309000016NR | Class C | Active |
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Manufacturer
- Manufacturer
- Medicon Hellas SA
- EUDAMED SRN
- GR-MF-000013625
Sources (9)
- EUDAMED 55f1e08d-b2ee-49c3-8e30-edfcac4a0882 61 fields · synced Jul 31, 2026
- EUDAMED 619805d8-27df-49d2-ab26-e2d9f7aa206f 61 fields · synced May 16, 2026
- EUDAMED c4e1cd60-fef2-4e05-9c68-ced9021b1cce 61 fields · synced May 16, 2026
- EUDAMED 7565c79b-5fb6-4277-a5d6-82e683ccc0e3 61 fields · synced May 17, 2026
- EUDAMED 49994be5-7dc3-45a8-a589-5ee3f78ddd4a 61 fields · synced May 18, 2026
- EUDAMED ee05ca7b-325d-44d0-be45-74e1af7997a0 61 fields · synced May 18, 2026
- EUDAMED 3bbe36c3-0d30-410b-970e-f3ceb3d9aeb7 61 fields · synced May 18, 2026
- EUDAMED d3ecd6fe-b81a-4f4f-bc20-7a92dfab7526 61 fields · synced May 18, 2026
- EUDAMED 7f169524-c884-4352-833f-966ad2e2b3eb 61 fields · synced Jul 23, 2026