Identity
- Trade Name
- OptraGate Assortimento EUDAMED
- Device Name
- OptraGate, OptraGate 2, GBT Visigate EUDAMED
- Model / Reference
- 577275RU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07615208461077 EUDAMED
- Basic UDI-DI
- 76152081XDAMS001US EUDAMED
- EMDN Code
- Q019002 DENTISTRY DAMS AND HOOKS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Liechtenstein EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
OptraGate Assortimento by Ivoclar Vivadent AG — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 76152081XDAMS001US | Class I | Active |
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Manufacturer
- Manufacturer
- Ivoclar Vivadent AG
- EUDAMED SRN
- LI-MF-000000522
Sources (1)
- EUDAMED 178185ef-6490-4849-8164-7e54c29dc673 61 fields · synced Jun 19, 2026