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Single-Use Flexible Cystoscope

by Unimicro Medical Systems (Shenzhen) Co., Ltd United States EUDAMED

Ref UNEN-BD50EModel UNEN-BD50A, UNEN-BD50B, UNEN-BD50C, UNEN-BD50D, UNEN-BD50E EMDN Z12020713

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69557977UNEN003DG Basic UDI-DIDate25 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Single-Use Flexible Cystoscope
Model / Reference
UNEN-BD50A, UNEN-BD50B, UNEN-BD50C, UNEN-BD50D, UNEN-BD50E
Primary DI / UDI-DI
06955797773559
Basic UDI-DI
69557977UNEN003DG
EMDN Code
Z12020713 Ureterorenoscopes
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000014590
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Unimicro Medical Systems (Shenzhen) Co., Ltd.

See all devices from Unimicro Medical Systems (Shenzhen) Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • 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

Sources (1)

  • EUDAMED 06955797773559|69557977UNEN003DG 61 fields · synced 25 Oct 2026