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AMECATH Percutaneous Sheath Introducer Kit

by Ameco medical industries 10 variants

Ref PSI-0605-HKModel As per 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Withdrawn Withdrawn in European Union.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Was authorized under CE MDR, withdrawn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Withdrawn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 Number6221139INV-PSI-2aLN Basic UDI-DI 06221139282875UDI-DIDate11 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  • Withdrawn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European Union — CE/MDR Withdrawn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 per Declaration of conformity, PSI-0605-HK
Primary DI / UDI-DI
06221139282875
Basic UDI-DI
6221139INV-PSI-2aLN
Direct Marketing DI
06221139282875
EMDN Code
C0502 Cardiovascular introducer sheaths, valved
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