Identity
- Trade Name
- Uric Acid T FL EUDAMED
- Device Name
- URIC ACID T FL EUDAMED
- Model / Reference
- AU F402 CH EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033650840001 EUDAMED
- Basic UDI-DI
- 803365084AUS9 EUDAMED
- Direct Marketing DI
- 08033650840001 EUDAMED
- EMDN Code
- W01010232 URIC ACID EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Category: Uric acid IVD, reagent
Uric Acid T FL by Chema Diagnostica Srl — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 803365084AUS9 | Class B | Active |
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Manufacturer
- Manufacturer
- Chema Diagnostica Srl
- EUDAMED SRN
- IT-MF-000009128
Sources (1)
- EUDAMED 3f1b30fc-deec-47d6-a6b5-67c258d38c4e 61 fields · synced Jun 19, 2026