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Orthodontic Anchor Screw

by BioMaterials Korea, Inc. EUDAMED

Active European Union

Ref Orthoplant-Bicortical-L-001Model Special Type

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08809744965109 Basic UDI-DIDate12 Feb 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

No EU certificate is linked to this device in EUDAMED.

Specification

EUDAMED

Device Name
Orthoplant-Bicortical-L
Model / Reference
Special Type, Orthoplant-Bicortical-L-001
Primary DI / UDI-DI
08809744965109
Basic UDI-DI
B-08809744965109
EMDN Code
Q010499 Orthodontic devices - other
Device Class
Class IIb
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
KR-MF-000019882
Authorised representative
KTR Europe GmbH DE-AR-000005685

Other devices from BioMaterials Korea, Inc.

See all devices from BioMaterials Korea, Inc. →

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: 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