Skip to content

Wellead Urethral Dilator

by Well Lead Medical Co., Ltd. China EUDAMED

Ref U02A050111Model Hydrophilic coating S Shape Dilator, Set

EMDN U03010201

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69449327FU02A05LK Basic UDI-DIDate1 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Urethral Dilator
Model / Reference
Hydrophilic coating S Shape Dilator, Set, U02A050111
Primary DI / UDI-DI
06925816634437
Basic UDI-DI
69449327FU02A05LK
EMDN Code
U03010201 Urethral dilators
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000006728
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Well Lead Medical Co., Ltd

See all devices from Well Lead Medical 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 06925816634437|69449327FU02A05LK 61 fields · synced 24 Oct 2026