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OptraGate 2 Regular Refill / 80

by Ivoclar Vivadent AG Liechtenstein EUDAMED

Ref 757912WW

EMDN Q019002

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number76152081XDAMS001US Basic UDI-DIDate13 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
OptraGate, OptraGate 2, GBT Visigate
Model / Reference
757912WW
Primary DI / UDI-DI
07615208592603
Basic UDI-DI
76152081XDAMS001US
Unit of Use DI
07615208601053
EMDN Code
Q019002 Dentistry dams and hooks, single-use
Device Class
Class I
Market of Registration
Liechtenstein

Manufacturer details

EUDAMED SRN
LI-MF-000000522

Other devices from Ivoclar Vivadent AG

See all devices from Ivoclar Vivadent AG →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 07615208592603|76152081XDAMS001US 61 fields · synced 24 Oct 2026