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İpek

by Doğsan Tibbi̇ Malzeme Sanayi̇ A.Ş. Türkiye EUDAMED

Ref S3255Model With needle(s)

EMDN H010202020301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8698147S010S0UA Basic UDI-DIDate17 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • MDR 00115-A Issued

    Quality management system EU MDR

    Notified body
    KIWA CERMET ITALIA S.P.A. 0476
    Issued
    27 Oct 2025
    Expires
    26 Oct 2030
  • MDR 00115-B Issued

    Technical documentation EU MDR

    Notified body
    KIWA CERMET ITALIA S.P.A. 0476
    Issued
    12 Dec 2025
    Expires
    26 Oct 2030

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
With needle(s), S3255
Primary DI / UDI-DI
08698147917682
Basic UDI-DI
8698147S010S0UA
EMDN Code
H010202020301 Silk with needle
Device Class
Class IIb
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000016026

Other devices from Doğsan Tibbi̇ Malzeme Sanayi̇ A.Ş.

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

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (12)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: 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

Sources (1)

  • EUDAMED 08698147917682|8698147S010S0UA 61 fields · synced 24 Oct 2026