Identity
- Trade Name
- Urea UV EUDAMED
- Device Name
- Urea UV EUDAMED
- Model / Reference
- 4170 EUDAMED4164 EUDAMED4164/50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053172970956 EUDAMED08053172970963 EUDAMED08053172970970 EUDAMED
- Basic UDI-DI
- B-08053172970956 EUDAMEDB-08053172970963 EUDAMEDB-08053172970970 EUDAMED
- EMDN Code
- W01010204 UREA/BLOOD UREA NITROGEN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
Urea UV by Giesse Diagnostics Srl — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08053172970956 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Giesse Diagnostics Srl
- EUDAMED SRN
- IT-MF-000039031
Sources (3)
- EUDAMED 6f0b58b5-4fa6-4f5d-b530-2204d5e01341 61 fields · synced Jul 31, 2026
- EUDAMED 87fcfeda-d988-4d1f-824b-a541c4b199bf 61 fields · synced May 18, 2026
- EUDAMED ad0656af-9801-467c-8c32-7ae0f356a5f0 61 fields · synced May 18, 2026