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T-Marker SW

by TruAbutment Inc. EUDAMED

Active European Union

Ref T-Marker SW

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88000764TSW35 Basic UDI-DIDate1 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Model / Reference
T-Marker SW
Primary DI / UDI-DI
08800076475632
Basic UDI-DI
88000764TSW35
EMDN Code
Z12119092 Various dental stomatology instruments - medical device software
Device Class
Class I
Special Device Type
Software
Market of Registration
France

Manufacturer details

EUDAMED SRN
US-MF-000043448
Authorised representative
AeMi World e.K DE-AR-000007704

Other devices from TruAbutment Inc.

See all devices from TruAbutment Inc. →

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