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AMECATH Ureteral Balloon Dilator

by Ameco medical industries EUDAMED

Withdrawn No longer placed on the EU market

Ref UBD-05-06Model As model attached on the Declaration of Conformity

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6221139URO-UBD-2aRC Basic UDI-DIDate11 Oct 2026RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Withdrawn

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

Model / Reference
As model attached on the Declaration of Conformity, UBD-05-06
Primary DI / UDI-DI
06221139003319
Basic UDI-DI
6221139URO-UBD-2aRC
Direct Marketing DI
06221139003319
EMDN Code
U030202 Ureteral dilators, with balloon
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
EG-MF-000028383
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Ameco Medical Industries

See all devices from Ameco Medical Industries →

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