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Onegel

by Kaf Grup Sağlik Hi̇zmetleri̇ İnşaat Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ EUDAMED

Active European Union

Ref KAFG27-6, KAFG27-11Model 6 mL, 11 mL

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08682560951507 Basic UDI-DIDate25 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
ONEGEL Lubricant Gel With Lidocaine (6 mL)
ONEGEL Lubricant Gel With Lidocaine (11 mL)
Model / Reference
6 mL, KAFG27-6, 11 mL, KAFG27-11
Primary DI / UDI-DI
08682560951507, 08682560951552, 08682560951569, 08682560951514
Basic UDI-DI
B-08682560951507, B-08682560951552, B-08682560951569, B-08682560951514
EMDN Code
V9007 Sterile instrument lubricants
Device Class
Class III
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000018530

Other devices from Kaf Grup Sağlik Hi̇zmetleri̇ İnşaat Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇

See all devices from Kaf Grup Sağlik Hi̇zmetleri̇ İnşaat Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ →

Properties

Show properties
  • Sterile
  • Incorporates Medicinal Product
Other properties (9)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No