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Orthodontic Anchor Screw

by BioMaterials Korea, Inc. 42 variants

Ref OAS-T1511H-001Model H Type

Active European Union

CE MDD

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/MDD NumberB-08809744967608 Basic UDI-DI 08809744967608UDI-DIDate12 Feb 2025RegisteredStatusActive

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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
Oas-T1511H
Model / Reference
H Type, OAS-T1511H-001
Primary DI / UDI-DI
08809744967608
Basic UDI-DI
B-08809744967608
EMDN Code
Q010499 Orthodontic devices - other
Device Class
Class IIb
EU 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