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UroViu 5000 Imaging Handle

by UroViu Corporation 2 variants

Ref 5000EUModel 5000EU, 5000WEU

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0850051518UV5000EU7P Basic UDI-DI 00850051518210UDI-DIDate20 Sep 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
UroViu 5000 Endoscope Display Handle
Model / Reference
5000EU, 5000WEU
Primary DI / UDI-DI
00850051518210
Basic UDI-DI
0850051518UV5000EU7P
Direct Marketing DI
00850051518210
EMDN Code
Z12020406 Video processors
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
US-MF-000039864
Authorised representative
Casus Europe B.V. NL-AR-000037688

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Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No