Identity
- Trade Name
- Creatinine (Enzymatic) EUDAMED
- Device Name
- Creatinine (Enzymatic) EUDAMED
- Model / Reference
- 981896 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16438153818967 EUDAMED
- Basic UDI-DI
- 6438153BU00130BF EUDAMED
- Direct Marketing DI
- 16438153818967 EUDAMED
- EMDN Code
- W01010207 CREATININE EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Finland 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 (Enzymatic) by Thermo Fisher Scientific Oy — Class B — FDA_510K, IVDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070824 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 6438153BU00130BF | Class B | Active |
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Manufacturer
- Manufacturer
- Thermo Fisher Scientific Oy
- EUDAMED SRN
- FI-MF-000001479
Sources (2)
- EUDAMED 5417f618-7913-48dc-8ae3-4dac17642e8d 61 fields · synced Oct 6, 2026
- FDA 510(k) K070824 1 fields · synced May 18, 2026