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Daxton-K

by Doğsan Tibbi̇ Malzeme Sanayi̇ A.Ş. EUDAMED

Active European Union

Ref XK41602Model With needle(s)

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2975-MED-2518901 Date8 Jul 2025IssuedStatusActive expires 7 Jul 2030

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2975-MED-2518901 Issued

    Quality management system EU MDR

    Notified body
    Notified body 2975
    Issued
    8 Jul 2025
    Expires
    7 Jul 2030
  • 2975-MED-2518901-D01 Issued

    Technical documentation EU MDR

    Notified body
    Notified body 2975
    Issued
    8 Jul 2025
    Expires
    7 Jul 2030

Specification

EUDAMED

Model / Reference
With needle(s), XK41602
Primary DI / UDI-DI
08698147930988
Basic UDI-DI
8698147S000XKW6
EMDN Code
H010201010501 Polytetrafluoroethylene (ptfe) monofilament with needle
Device Class
Class III
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000016026

Related devices

Category: Polyolefin/fluoropolymer suture, monofilament

Other devices from Doğsan Tibbi̇ Malzeme Sanayi̇ A.Ş.

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Properties

  • Sterile
  • Implantable

Other properties (11)

  • 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