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Zirtooth F O-98-F(10T)N

by Hass Corp. EUDAMED

Active European Union

Ref O-98-F(10T)NModel Zirtooth

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-08800057100119 Basic UDI-DIDate20 Oct 2026RegisteredStatusActive
European UnionCE/MDD NumberB-08800057100119 Basic UDI-DIDate20 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Zirtooth
Model / Reference
Zirtooth, O-98-F(10T)N
Primary DI / UDI-DI
08800057100119
Basic UDI-DI
B-08800057100119, 88000571TD701F2
EMDN Code
Q010699 Materials for the preparation of custom-made dental devices - other
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000011621
Authorised representative
KTR Europe GmbH DE-AR-000005685

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Properties

Show 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