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BM Ureteral Dilators

by Bonree Medical Co., Ltd. EUDAMED

Active European Union

Ref 405 16 22 2Model 6FR, 8FR, 9FR, 10FR, 11FR,12FR, 14FR, 16FR, 18FR

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697209192UED38KF Basic UDI-DIDate3 Jun 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  • Withdrawn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
Ureteral Dilators
Model / Reference
6FR, 8FR, 9FR, 10FR, 11FR, 12FR, 14FR, 16FR, 18FR, 405 16 22 2
Primary DI / UDI-DI
06972091926801
Basic UDI-DI
697209192UED38KF
Direct Marketing DI
06972091926801
EMDN Code
U03010202 Ureteral dilators
Device Class
Class IIa
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000017844
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Bonree Medical Co., Ltd.

See all devices from Bonree Medical 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