<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03760278260908</udiDi>
    <basicUdiDi>801337602782D0001CP</basicUdiDi>
    <tradeName>PSPIX2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOPRO</manufacturerName>
    <manufacturerSrn>FR-MF-000000833</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S_702_0006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:01:16.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760278260922</udiDi>
    <basicUdiDi>801337602782D0001CP</basicUdiDi>
    <tradeName>PSPIX2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOPRO</manufacturerName>
    <manufacturerSrn>FR-MF-000000833</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S_702_0010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:01:15.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760278260939</udiDi>
    <basicUdiDi>801337602782D0001CP</basicUdiDi>
    <tradeName>PSPIX2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOPRO</manufacturerName>
    <manufacturerSrn>FR-MF-000000833</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S_702_0011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:01:15.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760278262421</udiDi>
    <basicUdiDi>801337602782D0001CP</basicUdiDi>
    <tradeName>PSPIX2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOPRO</manufacturerName>
    <manufacturerSrn>FR-MF-000000833</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S_702_0013</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:01:15.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760278263688</udiDi>
    <basicUdiDi>801337602782D0001CP</basicUdiDi>
    <tradeName>PSPIX2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOPRO</manufacturerName>
    <manufacturerSrn>FR-MF-000000833</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S_702_0015</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:01:15.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>06430035420902</udiDi>
    <basicUdiDi>6430035420205H</basicUdiDi>
    <tradeName>KaVo ProXam iOS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Planmeca Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000006499</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30039722</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T14:34:07.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020509</udiDi>
    <basicUdiDi>081606302DISBH</basicUdiDi>
    <tradeName>iTero Element 5D Laptop Configuration</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>206160</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020561</udiDi>
    <basicUdiDi>081606302DISBH</basicUdiDi>
    <tradeName>iTero Element 5D Upgrade Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>206855</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020578</udiDi>
    <basicUdiDi>081606302DISBH</basicUdiDi>
    <tradeName>iTero Element 5D Laptop Configuration Upgrade Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>206856</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020684</udiDi>
    <basicUdiDi>081606302ELEMENT6L</basicUdiDi>
    <tradeName>iTero Element 2 Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211483</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020691</udiDi>
    <basicUdiDi>081606302DISBH</basicUdiDi>
    <tradeName>iTero Element 5D Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211484</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020738</udiDi>
    <basicUdiDi>081606302ELEMENT6L</basicUdiDi>
    <tradeName>iTero Element 2 Plus Mobile configuration</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211490</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020745</udiDi>
    <basicUdiDi>081606302DISBH</basicUdiDi>
    <tradeName>iTero Element 5D Plus Mobile Configuration</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211491</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.066Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020851</udiDi>
    <basicUdiDi>081606302ELEMENT6L</basicUdiDi>
    <tradeName>iTero Element 2 Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211782</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:49.990Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020868</udiDi>
    <basicUdiDi>081606302DISBH</basicUdiDi>
    <tradeName>E5D Plus Scanning Unit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211783</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:49.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020905</udiDi>
    <basicUdiDi>081606302ELEMENT6L</basicUdiDi>
    <tradeName>iTero Element Flex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>212094</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:49.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020912</udiDi>
    <basicUdiDi>081606302ELEMENT6L</basicUdiDi>
    <tradeName>iTero Element 2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>212095</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:49.937Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020929</udiDi>
    <basicUdiDi>081606302DISBH</basicUdiDi>
    <tradeName>iTero Element 5D Rental</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>212096</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:49.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020936</udiDi>
    <basicUdiDi>081606302DISBH</basicUdiDi>
    <tradeName>iTero Element 5D Laptop Configuration</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>212097</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:49.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020998</udiDi>
    <basicUdiDi>081606302ELEMENT6L</basicUdiDi>
    <tradeName>iTero Element™ 2 Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211889</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:49.865Z</lastUpdated>
  </row>
</eudamedExport>