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Single-use Flexible Cystoscope

by Asieris Pharmaceuticals (Shanghai) Co., Ltd EUDAMED

Active European Union

Ref Asieris-BL-C001

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6979155882304Urol01Z9 Basic UDI-DIDate8 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

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.

Specification

EUDAMED

Device Name
Single-use Flexible Cystoscope
Model / Reference
Asieris-BL-C001
Primary DI / UDI-DI
06979155880017
Basic UDI-DI
6979155882304Urol01Z9
EMDN Code
Z12020701 Cystoscopes
Device Class
Class IIa
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000050276
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Asieris Pharmaceuticals (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