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Op-1870-2

by Europack Uluslararasi Sağlik Ve Spor Ürünleri Anoni̇m Şi̇rketi̇

Ref OP-1870-2Model OP-1000 /.../ OP-2505

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number86839072OP001SW Basic UDI-DI 08683907212831UDI-DIDate2 May 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Orthopedics Support Orthoses
Model / Reference
OP-1000 /.../ OP-2505, OP-1870-2
Primary DI / UDI-DI
08683907212831
Basic UDI-DI
86839072OP001SW
Direct Marketing DI
08683907212831
EMDN Code
M030599 Immobilisation systems and devices - other
Device Class
Class I
EU 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

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