<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06975362030740</udiDi>
    <basicUdiDi>697536203LMNSYSUZ</basicUdiDi>
    <tradeName>iTero Lumina Intraoral Scanner</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology (Sichuan) Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024868</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>229821</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:48:09.549Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975362030757</udiDi>
    <basicUdiDi>697536203LMNSYSUZ</basicUdiDi>
    <tradeName>iTero Lumina Intraoral Scanner/iTero Lumina Mobile</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology (Sichuan) Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024868</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>229823</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:47:27.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975362030696</udiDi>
    <basicUdiDi>697536203LMNSYSUZ</basicUdiDi>
    <tradeName>Lumina Wand</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology (Sichuan) Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024868</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>229860</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:47:26.495Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975362030580</udiDi>
    <basicUdiDi>697536203LMNSYSUZ</basicUdiDi>
    <tradeName>Wheel Stand</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology (Sichuan) Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024868</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211384</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:47:24.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975362030795</udiDi>
    <basicUdiDi>697536203LMNSYSUZ</basicUdiDi>
    <tradeName>DOA, iTero Lumina</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology (Sichuan) Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024868</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>229856</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:47:09.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975362030832</udiDi>
    <basicUdiDi>697536203LMNSYSUZ</basicUdiDi>
    <tradeName>RMA, Replacement, Scanning Unit Lumina</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology (Sichuan) Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024868</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>229819</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:47:08.113Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975362030801</udiDi>
    <basicUdiDi>697536203LMNSYSUZ</basicUdiDi>
    <tradeName>RMA, Lumina PPC Replacement</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology (Sichuan) Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024868</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>222974</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:46:38.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975362030849</udiDi>
    <basicUdiDi>697536203LMNSYSUZ</basicUdiDi>
    <tradeName>RMA, Wheel Stand Replacement</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology (Sichuan) Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024868</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>223153</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:38:50.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975362030535</udiDi>
    <basicUdiDi>697536203LMNSLVTY</basicUdiDi>
    <tradeName>iTero Lumina Scanner Sleeve</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology (Sichuan) Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024868</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>223141</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:38:31.447Z</lastUpdated>
  </row>
</eudamedExport>