Identity
- Trade Name
- UroViu 4500 Imaging Handle EUDAMED
- Device Name
- UroViu 4500 Endoscope Display Handle EUDAMED
- Model / Reference
- 4500EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850051518135 EUDAMED
- Basic UDI-DI
- 08500515184500EU5H EUDAMED
- Direct Marketing DI
- 00850051518135 EUDAMED
- EMDN Code
- Z12020406 VIDEO PROCESSORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
UroViu 4500 Imaging Handle by UroViu Corporation — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08500515184500EU5H | Class I | Active |
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Manufacturer
- Manufacturer
- UroViu Corporation
- EUDAMED SRN
- US-MF-000039864
- Authorised Representative
- Casus Europe B.V. NL-AR-000037688
Sources (1)
- EUDAMED 63298ea7-10de-4c2d-a913-c5536a605fe7 61 fields · synced Jul 12, 2026