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<eudamedExport entity="devices">
  <row>
    <udiDi>00816063020165</udiDi>
    <basicUdiDi>B-00816063020165</basicUdiDi>
    <tradeName>Invisalign System</tradeName>
    <deviceName>Invisalign System</deviceName>
    <manufacturerName>Align Technology Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000000744</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8800</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:29:27.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020028</udiDi>
    <basicUdiDi>B-00816063020028</basicUdiDi>
    <tradeName>Vivera Retainer</tradeName>
    <deviceName>Vivera Retainer</deviceName>
    <manufacturerName>Align Technology Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000000744</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7883</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:29:26.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020301</udiDi>
    <basicUdiDi>081606302CCrystalsRM</basicUdiDi>
    <tradeName>Invisalign Cleaning Crystals 250 pcs</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>PRODUCTS FOR CLEANING MEDICAL DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>76009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020318</udiDi>
    <basicUdiDi>081606302CCrystalsRM</basicUdiDi>
    <tradeName>Invisalign Cleaning Crystals 50 pcs</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>PRODUCTS FOR CLEANING MEDICAL DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020325</udiDi>
    <basicUdiDi>081606302PliersWK</basicUdiDi>
    <tradeName>Invisalign Eraser Pliers</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>ORTHODONTIC PLIERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>76016</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020332</udiDi>
    <basicUdiDi>081606302PliersWK</basicUdiDi>
    <tradeName>Invisalign Detail Pliers</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>ORTHODONTIC PLIERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>76017</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020349</udiDi>
    <basicUdiDi>081606302ImpTrayCC</basicUdiDi>
    <tradeName>Invisalign Impression Tray, Plastic, Upper, Small</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>IMPRESSION MATERIAL TRAYS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2562</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020356</udiDi>
    <basicUdiDi>081606302ImpTrayCC</basicUdiDi>
    <tradeName>Invisalign Impression Tray, Plastic, Upper, X-Large</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>IMPRESSION MATERIAL TRAYS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2563</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020363</udiDi>
    <basicUdiDi>081606302ImpTrayCC</basicUdiDi>
    <tradeName>Invisalign Impression Tray, Plastic, Upper, Large</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>IMPRESSION MATERIAL TRAYS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2564</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.305Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020370</udiDi>
    <basicUdiDi>081606302ImpTrayCC</basicUdiDi>
    <tradeName>Invisalign Impression Tray, Plastic, Upper, Medium</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>IMPRESSION MATERIAL TRAYS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2565</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020387</udiDi>
    <basicUdiDi>081606302ImpTrayCC</basicUdiDi>
    <tradeName>Invisalign Impression Tray, Plastic, Lower, X-Large</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>IMPRESSION MATERIAL TRAYS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2566</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020394</udiDi>
    <basicUdiDi>081606302ImpTrayCC</basicUdiDi>
    <tradeName>Invisalign Impression Tray, Plastic, Lower, Large</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>IMPRESSION MATERIAL TRAYS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2567</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020400</udiDi>
    <basicUdiDi>081606302ImpTrayCC</basicUdiDi>
    <tradeName>Invisalign Impression Tray, Plastic, Lower, Medium</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>IMPRESSION MATERIAL TRAYS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2568</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020417</udiDi>
    <basicUdiDi>081606302ImpTrayCC</basicUdiDi>
    <tradeName>Invisalign Impression Tray, Plastic, Lower, Small</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>IMPRESSION MATERIAL TRAYS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2569</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020424</udiDi>
    <basicUdiDi>081606302InvisalignMH</basicUdiDi>
    <tradeName>Invisalign Go</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020431</udiDi>
    <basicUdiDi>081606302InvisalignMH</basicUdiDi>
    <tradeName>Invisalign Go Plus</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020493</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>205929</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.210Z</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>UNKNOWN</legislation>
    <emdnCode></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>00816063020530</udiDi>
    <basicUdiDi>081606302InvisalignMH</basicUdiDi>
    <tradeName>Invisalign Touch-up</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9023</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.185Z</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>206855</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.167Z</lastUpdated>
  </row>
</eudamedExport>