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DuraSheath Introducer Sheath System

by Contract Medical International GmbH 64 variants

Ref FG-05060-F-LIMA

Expiring European Union

CE MDR

Valid until

1 Jun 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2254506TD01 Date20 Nov 2025IssuedStatusExpiring expires 1 Jun 2027

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2254506CE01 Expiring Expires in 212 days

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    25 Jun 2022
    Expires
    1 Jun 2027
  • 2254506TD01 Expiring Supplemented Expires in 212 days

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    20 Nov 2025
    Expires
    1 Jun 2027
    Reason
    Change approved

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Expiring

Specification

EUDAMED

Model / Reference
FG-05060-F-LIMA
Primary DI / UDI-DI
04251244503147
Basic UDI-DI
4251244500000013C
EMDN Code
C0502 Cardiovascular introducer sheaths, valved
Device Class
Class III
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000007409

Other devices from Contract Medical International GmbH

See all devices from Contract Medical International GmbH →

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