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Politer

by Doğsan Tibbi̇ Malzeme Sanayi̇ A.Ş. Türkiye EUDAMED

Ref R1882Model With or without needle(s)

EMDN H010201020201,H010201020202

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8698147S010R0U7 Basic UDI-DIDate4 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • 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 · synced 25 Oct 2026

Model / Reference
With or without needle(s), R1882
Primary DI / UDI-DI
08698147916012
Basic UDI-DI
8698147S010R0U7
EMDN Code
H010201020201,H010201020202
Device Class
Class III
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 (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

Sources (1)

  • EUDAMED 08698147916012|8698147S010R0U7 61 fields · synced 25 Oct 2026