Identity
- Trade Name
- Uric Acid (AOX) EUDAMED
- Device Name
- Uric Acid (AOX) EUDAMED
- Model / Reference
- 981788 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16438153817885 EUDAMED
- Basic UDI-DI
- 6438153BU00186CA EUDAMEDB-16438153817885 EUDAMED
- Direct Marketing DI
- 16438153817885 EUDAMED
- EMDN Code
- W01010232 URIC ACID EUDAMED
Classification
- Device Class
- Class B EUDAMEDClass IVD General 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
Uric Acid (AOX) by Thermo Fisher Scientific Oy — Class B — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 6438153BU00186CA | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 6438153BU00186CA | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Thermo Fisher Scientific Oy
- EUDAMED SRN
- FI-MF-000001479
Sources (2)
- EUDAMED c41a525b-3668-447f-9e38-f486a0aa1b1d 61 fields · synced Oct 6, 2026
- EUDAMED 500c3d53-a49c-4290-9a8b-75224d17f37d 61 fields · synced Oct 6, 2026