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OneGuide KIT

by OSSTEM IMPLANT Co., Ltd. South Korea EUDAMED

Ref OOGK EMDN L159016

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800000963440 Basic UDI-DIDate2 Jun 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  • Withdrawn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 · synced 25 Oct 2026

Model / Reference
OOGK
Primary DI / UDI-DI
08800000963440
Basic UDI-DI
B-08800000963440
EMDN Code
L159016 Dental surgery instrument kits, reusable
Device Class
Class IIa
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
KR-MF-000020006
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Osstem Implant Co., Ltd

See all devices from Osstem Implant Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Reusable
Other properties (10)
  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 08800000963440|B-08800000963440 61 fields · synced 25 Oct 2026