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    <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>
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    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>206856</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.149Z</lastUpdated>
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    <udiDi>00816063020585</udiDi>
    <basicUdiDi>081606302SLEEVE6S</basicUdiDi>
    <tradeName>iTero Element Scanner Sleeve</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>VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - CONSUMABLES</emdnDescription>
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    <placedOnMarketCountry></placedOnMarketCountry>
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    <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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.112Z</lastUpdated>
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    <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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211484</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.094Z</lastUpdated>
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  <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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211490</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.080Z</lastUpdated>
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  <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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211491</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.066Z</lastUpdated>
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  <row>
    <udiDi>00816063020820</udiDi>
    <basicUdiDi>0081606302WS7C</basicUdiDi>
    <tradeName>iTero Wheel Stand</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>PROSTHETIC DENTISTRY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211384</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.043Z</lastUpdated>
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  <row>
    <udiDi>00816063020837</udiDi>
    <basicUdiDi>0081606302PlusCUKH</basicUdiDi>
    <tradeName>iTero Plus Computing 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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211385</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.026Z</lastUpdated>
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  <row>
    <udiDi>00816063020844</udiDi>
    <basicUdiDi>0081606302PlusMCU5U</basicUdiDi>
    <tradeName>iTero Plus Mobile Computing 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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211386</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.008Z</lastUpdated>
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  <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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211782</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:49.990Z</lastUpdated>
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    <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>UNKNOWN</legislation>
    <emdnCode></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>212094</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:49.954Z</lastUpdated>
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  <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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>212095</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:49.937Z</lastUpdated>
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  <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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>212096</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:49.918Z</lastUpdated>
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  <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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>212097</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:49.900Z</lastUpdated>
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    <udiDi>00816063020981</udiDi>
    <basicUdiDi>0081606302WS7C</basicUdiDi>
    <tradeName>iTero Element Plus Wheel Stand, 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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211563</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:49.882Z</lastUpdated>
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    <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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211889</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:49.865Z</lastUpdated>
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    <udiDi>00816063021001</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>212260</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:49.848Z</lastUpdated>
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    <udiDi>00816063021032</udiDi>
    <basicUdiDi>0081606302PlusCUKH</basicUdiDi>
    <tradeName>iTero Plus Computing 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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>209865</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:49.830Z</lastUpdated>
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    <udiDi>00816063021049</udiDi>
    <basicUdiDi>0081606302PlusCUKH</basicUdiDi>
    <tradeName>iTero Plus Computing 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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>212265</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:49.812Z</lastUpdated>
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