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<eudamedExport entity="devices">
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    <udiDi>00816063022251</udiDi>
    <basicUdiDi>081606302IOCPRO5A</basicUdiDi>
    <tradeName>iTero Lumina Pro Scanning Unit, RMA Package</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>221955</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063022275</udiDi>
    <basicUdiDi>081606302IOCPRO5A</basicUdiDi>
    <tradeName>iTero Lumina Pro Scanning Unit, RMA Package</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>221956</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063022473</udiDi>
    <basicUdiDi>081606302DISBH</basicUdiDi>
    <tradeName>iTero Element 5D</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>218557</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.850Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063022480</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>218556</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063022497</udiDi>
    <basicUdiDi>081606302ELEMENT6L</basicUdiDi>
    <tradeName>iTero Element Flex CPO</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>218530</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063022503</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>217110</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063022527</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>217106</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.775Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063022534</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>217105</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.758Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063022541</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>217102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063022565</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>207279</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063022596</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>217604</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063022671</udiDi>
    <basicUdiDi>081606302IOCPRO5A</basicUdiDi>
    <tradeName>iTero Lumina Pro Scanning Unit, RMA</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>222048</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063022749</udiDi>
    <basicUdiDi>081606302InvisalignLensGZ</basicUdiDi>
    <tradeName>Invisalign lens (Std EU Core)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000000744</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>223594</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063022756</udiDi>
    <basicUdiDi>081606302InvisalignLensGZ</basicUdiDi>
    <tradeName>Invisalign lens (Std EU Secondary)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000000744</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>223596</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063022787</udiDi>
    <basicUdiDi>081606302InvisalignLensGZ</basicUdiDi>
    <tradeName>Invisalign lens (Sm EU Core)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000000744</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>223595</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.609Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063022794</udiDi>
    <basicUdiDi>081606302InvisalignLensGZ</basicUdiDi>
    <tradeName>Invisalign lens (Sm EU Secondary)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000000744</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>223597</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063022831</udiDi>
    <basicUdiDi>081606302LMNSYS9L</basicUdiDi>
    <tradeName>iTero Lumina Cart 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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>221961</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.571Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063022848</udiDi>
    <basicUdiDi>081606302LMNSYS9L</basicUdiDi>
    <tradeName>iTero Lumina 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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>221962</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063022893</udiDi>
    <basicUdiDi>081606302LMNSYS9L</basicUdiDi>
    <tradeName>iTero Lumina 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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>224166</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063022916</udiDi>
    <basicUdiDi>081606302LMNSYS9L</basicUdiDi>
    <tradeName>iTero Scanning Unit Lumina</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>222984</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:48.497Z</lastUpdated>
  </row>
</eudamedExport>