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AMECATH Disposable Cartridge

by Ameco medical industries 5 variants

Ref DC03-FMModel As attached in the Declaration of Conformity

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6221139URO-UDC-2aRT Basic UDI-DI 06221139140304UDI-DIDate28 Sep 2026RegisteredStatusActive

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  • Withdrawn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 Active

Specification

EUDAMED

Device Name
AMECATH Urodynamic Catheter Kit
Model / Reference
As attached in the Declaration of Conformity, DC03-FM
Primary DI / UDI-DI
06221139140304
Basic UDI-DI
6221139URO-UDC-2aRT
Direct Marketing DI
06221139140304
EMDN Code
U0580 Urodynamics devices - accessories
Device Class
Class IIa
EU market of registration
Germany

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