Skip to content

Single-use Flexible Video Ureterorenoscope

by Himaging Technology (Shanghai) Co., Ltd. EUDAMED

Active European Union

Ref DURS1-121PSModel DURS1-121P, DURS1-121PR,DURS1-121PS,DURS1-121PRS,DURS1-120P,DURS1-120PR,DURS1-120PS,DURS1-120PRS

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697423540DURSN4 Basic UDI-DIDate3 Nov 2025RegisteredStatusActive

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  • Withdrawn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

Model / Reference
DURS1-121P, DURS1-121PR, DURS1-121PS, DURS1-121PRS, DURS1-120P, DURS1-120PR, DURS1-120PS, DURS1-120PRS
Primary DI / UDI-DI
06974235401106
Basic UDI-DI
697423540DURSN4
EMDN Code
Z12020713 Ureterorenoscopes
Device Class
Class IIa
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
CN-MF-000028002
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Himaging Technology (Shanghai) Co., Ltd.

See all devices from Himaging Technology (Shanghai) Co., Ltd. →

Properties

Show properties
  • 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