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Otomati̇k Ekartör Künt 10 Cm

by Karbon Medi̇kal San. Ve Ti̇c. Ltd. Şti̇.

Ref OM 1061

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8680745OEKTBM Basic UDI-DI 08680745021571UDI-DIDate10 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Otomati̇k Ekartörler
Model / Reference
OM 1061
Primary DI / UDI-DI
08680745021571
Basic UDI-DI
8680745OEKTBM
Direct Marketing DI
08680745021571
EMDN Code
L03140199 Spreaders and retractors for general surgery, reusable - other
Device Class
Class I
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000047290

Other devices from Karbon Medi̇kal San. Ve Ti̇c. Ltd. Şti̇.

See all devices from Karbon Medi̇kal San. Ve Ti̇c. Ltd. Şti̇. →

Properties

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: 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