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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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OptraGate, OptraGate 2, GBT Visigate — 15 UDI-DI variants, MDR

MD Atlas
Ivoclar Vivadent AG

Data from EUDAMED, last updated May 30, 2026

OptraGate, OptraGate 2, GBT Visigate

76152081XDAMS001US

15 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class I

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Manufacturer: Ivoclar Vivadent AG

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 76152081XDAMS001US
Device name: OptraGate, OptraGate 2, GBT Visigate
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Nov 17, 2025

Manufacturer & authorised representative

Manufacturer

Name: Ivoclar Vivadent AG
SRN: LI-MF-000000522
Country: Liechtenstein
Email: Sandro.Sbicego@ivoclar.com

Variants by status

UDI-DI variants

15 UDI-DI variants

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Applied filters

basicUdiUlid01K9YRE5CQW4R6G0BJA78KCQ3S

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

GBT Visigate Marketing Kit / 1/107615208474183
GBT Visigate Regular / 6007615208474152
GBT Visigate Small / 6007615208473940
GBT Visigate Small + Regular / 30/3007615208474169
GBT Visigate Starter Kit / 15/1507615208474176
OptraGate 2 Assortment07615208516982
OptraGate 2 Test Pack 2x107615208513660
OptraGate Assortment07615208580396
OptraGate Assortment07615208461077
OptraGate Junior Refill/8007615208460841
OptraGate Regular Refill / 8007615208461060
OptraGate Regular Refill / 8007615208580402
OptraGate Small Refill / 8007615208580419
OptraGate Small Refill / 8007615208461053
OptraGate Test Pack 2x107615208484076