Skip to content

AMECATH Urethral Balloon Catheter

by Ameco medical industries 14 variants

Ref F-TS-16-2Model As the models attached on Declaration of Conformity

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6221139URO-UBC-2aR5 Basic UDI-DI 06221139005979UDI-DIDate14 Oct 2026RegisteredStatusWithdrawn No longer placed on the EU market

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  • Withdrawn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European Union — CE/MDR Withdrawn

Specification

EUDAMED

Model / Reference
As the models attached on Declaration of Conformity, F-TS-16-2
Primary DI / UDI-DI
06221139005979
Basic UDI-DI
6221139URO-UBC-2aR5
Direct Marketing DI
06221139005979
EMDN Code
U010299 Urethral prostatic and bladder catheters, with balloon - other
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