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Titanium Guide Tube

by OsteoCare Implant System Limited

Ref CO-TGT-001Model Guide Tubes

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506091295GuideTubesKX Basic UDI-DI 50609129522742UDI-DIDate30 Sep 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Titanium Guide Tubes
Model / Reference
Guide Tubes, CO-TGT-001
Primary DI / UDI-DI
50609129522742
Basic UDI-DI
506091295GuideTubesKX
EMDN Code
P01020180 Dental implants - accessories
Device Class
Class I
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000016843
Authorised representative
OsteoCare Implant System Ireland Limited IE-AR-000009841

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See all devices from OsteoCare Implant System Limited →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: 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