Skip to content

Single-Use Flexible Ureteroscope

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

Ref UNC-UT31AModel UNC-UT25A, UNC-UT25B, UNC-UT25C, UNC-UT25D, UNC-UT25E, UNC-UT31A, UNC-UT31B, UNC-UT31C, UNC-UT31D, UNC-UT31E

EMDN Z12020713

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69557977UNEN002DE Basic UDI-DIDate25 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Single-Use Flexible Ureteroscope
Model / Reference
UNC-UT25A, UNC-UT25B, UNC-UT25C, UNC-UT25D, UNC-UT25E, UNC-UT31A, UNC-UT31B, UNC-UT31C, UNC-UT31D, UNC-UT31E
Primary DI / UDI-DI
06955797773313
Basic UDI-DI
69557977UNEN002DE
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 06955797773313|69557977UNEN002DE 61 fields · synced 25 Oct 2026