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Op-1195

by Europack Uluslararasi Sağlik Ve Spor Ürünleri Anoni̇m Şi̇rketi̇ Türkiye EUDAMED

Ref OP-1195Model OP-1000 /.../ OP-2505

EMDN Y210924

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number86839072OP001SW Basic UDI-DIDate2 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Orthopedics Support Orthoses
Model / Reference
OP-1000 /.../ OP-2505, OP-1195
Primary DI / UDI-DI
08683907213302
Basic UDI-DI
86839072OP001SW
Direct Marketing DI
08683907213302
EMDN Code
Y210924 Arm supports
Device Class
Class I
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000038879

Other devices from Europack Uluslararasi Sağlik Ve Spor Ürünleri Anoni̇m Şi̇rketi̇

See all devices from Europack Uluslararasi Sağlik Ve Spor Ürünleri Anoni̇m Şi̇rketi̇ →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • 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

Sources (1)

  • EUDAMED 5c682d84-cbac-45f1-863a-25652d3043ac 61 fields · synced 23 Oct 2026