Skip to content

Guidewires for Peripheral Application

by EPflex Feinwerktechnik GmbH 36 variants

Ref GWPTC-035-90-5_5

Active European Union

CE MDR

Valid until

8 Nov 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number1000265993 Date27 Oct 2025IssuedStatusActive expires 8 Nov 2028

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000265993 Active

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    27 Oct 2025
    Expires
    8 Nov 2028

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Guidewires for Peripheral Application
Model / Reference
GWPTC-035-90-5_5
Primary DI / UDI-DI
04255605609271
Basic UDI-DI
42556056gwcIIaFP
EMDN Code
U0601 Urological guidewires, hydrophilic
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005425

Other devices from Epflex Feinwerktechnik GmbH

See all devices from Epflex Feinwerktechnik GmbH →

Properties

  • Sterile
  • CMR Substance

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No