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LineaTM

by medK GmbH 120 variants

Ref 98260J3FC260PTFE035Model MedK Diagnostic Guidewires

Active European Union

CE MDR

Valid until

12 Oct 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DNV MEDCERT GmbH

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 Number20610GB450260729 Date29 Jul 2026IssuedStatusActive expires 12 Oct 2030

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 20610GB450260729 Active Supplemented

    Technical documentation EU MDR

    Certifier
    DNV MEDCERT GmbH 0482
    Issued
    29 Jul 2026
    Expires
    12 Oct 2030
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
MedK Diagnostic Guidewires
Model / Reference
MedK Diagnostic Guidewires, 98260J3FC260PTFE035
Primary DI / UDI-DI
+B82798260J3FC260PTFE0351
Basic UDI-DI
++B82798260LF
EMDN Code
C04030102 Diagnostic coronary and peripheral vascular guide wires, non-hydrophilic
Device Class
Class III
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000006273

Other devices from medK GmbH

See all devices from medK 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