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OptraGate Small Refill / 80

by Ivoclar Vivadent AG 3 variants

Ref 590851US

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number76152081XDAMS001US Basic UDI-DI 07615208580419UDI-DIDate13 Nov 2025RegisteredStatusActive

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  • Withdrawn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
OptraGate, OptraGate 2, GBT Visigate
Model / Reference
590851US
Primary DI / UDI-DI
07615208580419
Basic UDI-DI
76152081XDAMS001US
Unit of Use DI
07615208582963
EMDN Code
Q019002 Dentistry dams and hooks, single-use
Device Class
Class I
EU 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

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