Identity
- Trade Name
- UROCULTOR ONEDIA 60 ML EUDAMED
- Device Name
- UROCULTOR 120 ml EUDAMED
- Model / Reference
- UO0460 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05944751005301 EUDAMED
- Basic UDI-DI
- 5944751IVDRU7B EUDAMED
- Direct Marketing DI
- 05944751005301 EUDAMED
- EMDN Code
- W05010203 URINE COLLECTION, CONTAINERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Urocultor Onedia 60 Ml by Sc Spd Star Srl — Class A — 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 | 5944751IVDRU7B | Class A | Active |
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Manufacturer
- Manufacturer
- Sc Spd Star Srl
- EUDAMED SRN
- RO-MF-000004404
Sources (1)
- EUDAMED a5fd1707-a409-4ebd-8c3a-9557974a1cb6 61 fields · synced Jun 19, 2026