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Daxton-D

by Doğsan Tibbi̇ Malzeme Sanayi̇ A.Ş. 27 variants

Ref XD1812Model With needle(s)

Active European Union

CE MDR

Valid until

7 Jul 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier SZUTEST Konformitätsbewertungsstelle 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 Number2975-MED-2518901 Date8 Jul 2025IssuedStatusActive expires 7 Jul 2030

Certificates

2 certificates · EUDAMED

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

    Quality management system EU MDR

    Certifier
    SZUTEST Konformitätsbewertungsstelle GmbH 2975
    Issued
    8 Jul 2025
    Expires
    7 Jul 2030
  • 2975-MED-2518901-D01 Active

    Technical documentation EU MDR

    Certifier
    SZUTEST Konformitätsbewertungsstelle GmbH 2975
    Issued
    8 Jul 2025
    Expires
    7 Jul 2030

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
With needle(s), XD1812
Primary DI / UDI-DI
08698147935570
Basic UDI-DI
8698147S000XDVQ
EMDN Code
H010201010501 Polytetrafluoroethylene (ptfe) monofilament with needle
Device Class
Class III
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000016026

Other devices from Doğsan Tibbi̇ Malzeme Sanayi̇ A.Ş.

  • Daxton-K

    Class III
  • Politer

    Class III
  • Propilen

    Class III
  • Xnat-Pedesente

    Class III
  • İpek

    Class IIb
  • PEGELAK rapid

    Class III

See all devices from Doğsan Tibbi̇ Malzeme Sanayi̇ A.Ş. →

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