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Single-use Flexible Video Ureterorenoscope

by Himaging Technology (Shanghai) Co., Ltd. 8 variants

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

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697423540DURSN4 Basic UDI-DI 06974235401182UDI-DIDate3 Nov 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
DURS1-121P, DURS1-121PR, DURS1-121PS, DURS1-121PRS, DURS1-120P, DURS1-120PR, DURS1-120PS, DURS1-120PRS
Primary DI / UDI-DI
06974235401182
Basic UDI-DI
697423540DURSN4
EMDN Code
Z12020713 Ureterorenoscopes
Device Class
Class IIa
EU 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

  • 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