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<eudamedExport entity="devices">
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    <udiDi>04719876733122</udiDi>
    <basicUdiDi>471987675KT0006JZ</basicUdiDi>
    <tradeName>Prosthetic Surgical Kit</tradeName>
    <deviceName>Prosthetic Surgical Kit</deviceName>
    <manufacturerName>INTAI Technology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000001158</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0748-001-DI0SK00074</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:18:52.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719876733085</udiDi>
    <basicUdiDi>471987675PR0003L6</basicUdiDi>
    <tradeName>aZure Screw-Retained Abutment, Bone Profiler, Small</tradeName>
    <deviceName>Profiler</deviceName>
    <manufacturerName>INTAI Technology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000001158</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIASK00006</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:18:51.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874672843</udiDi>
    <basicUdiDi>471987675DR0002F8</basicUdiDi>
    <tradeName>aZure Handpiece Implant Driver, Small, Short</tradeName>
    <deviceName>Implant Driver</deviceName>
    <manufacturerName>INTAI Technology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000001158</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK00065</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:18:05.270Z</lastUpdated>
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  <row>
    <udiDi>04719874672331</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure Lance Drill, 2mm</tradeName>
    <deviceName>Drill</deviceName>
    <manufacturerName>INTAI Technology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000001158</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK00002</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:18:04.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874672317</udiDi>
    <basicUdiDi>471987675KT0009K7</basicUdiDi>
    <tradeName>E-System Implant Surgical Kit, Premium</tradeName>
    <deviceName>E-System Implant Surgical Kit, Premium</deviceName>
    <manufacturerName>INTAI Technology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000001158</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0748-DI0SK00073E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:18:03.672Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874672300</udiDi>
    <basicUdiDi>471987675KT0008K5</basicUdiDi>
    <tradeName>C-System Implant Surgical Kit, Premium</tradeName>
    <deviceName>C-System Implant Surgical Kit, Premium</deviceName>
    <manufacturerName>INTAI Technology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000001158</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0748-DI0SK00073C</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:18:02.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874672294</udiDi>
    <basicUdiDi>471987675KT0007K3</basicUdiDi>
    <tradeName>C &amp; E System Implant Surgical Kit, Premium</tradeName>
    <deviceName>C &amp; E System Implant Surgical Kit, Premium</deviceName>
    <manufacturerName>INTAI Technology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000001158</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0748-DI0SK00073</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:18:02.074Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874672270</udiDi>
    <basicUdiDi>471987675KT0005JX</basicUdiDi>
    <tradeName>E-System Implant Surgical Kit, Standard</tradeName>
    <deviceName>E-System Implant Surgical Kit, Standard</deviceName>
    <manufacturerName>INTAI Technology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000001158</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0748-DI0SK00036E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:18:01.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874672263</udiDi>
    <basicUdiDi>471987675KT0004JV</basicUdiDi>
    <tradeName>C-System Implant Surgical Kit, Standard</tradeName>
    <deviceName>C-SYSTEM IMPLANT SURGICAL KIT, STANDARD</deviceName>
    <manufacturerName>INTAI Technology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000001158</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0748-DI0SK00030C</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:18:00.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719876733115</udiDi>
    <basicUdiDi>471987675PR0003L6</basicUdiDi>
    <tradeName>Screw-Retained Abutment, Bone Profiler Pin,  Large</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INTAI Technology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000001158</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIASK00009</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:32:19.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719876733108</udiDi>
    <basicUdiDi>471987675PR0003L6</basicUdiDi>
    <tradeName>Screw-Retained Abutment, Bone Profiler Pin,  Small</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INTAI Technology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000001158</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIASK00008</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:32:18.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719876733092</udiDi>
    <basicUdiDi>471987675PR0003L6</basicUdiDi>
    <tradeName>aZure Screw-Retained Abutment, Bone Profiler, Large</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INTAI Technology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000001158</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIASK00007</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:32:17.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719876733061</udiDi>
    <basicUdiDi>471987675DR0002F8</basicUdiDi>
    <tradeName>aZure As Driver, Long, CA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INTAI Technology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000001158</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK00079</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:32:09.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719876733054</udiDi>
    <basicUdiDi>471987675DR0002F8</basicUdiDi>
    <tradeName>As Driver, Short, CA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INTAI Technology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000001158</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK00078</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:32:08.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874673802</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure E-system Implant tap, 5 mm (D)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INTAI Technology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000001158</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20023</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:21:35.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874673796</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure E-system Implant tap, 4.5 mm (D)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INTAI Technology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000001158</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20022</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:21:34.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874673789</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure E-system Implant tap, 4 mm (D)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INTAI Technology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000001158</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20021</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:21:33.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874673772</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure E-system Implant tap, 3.5 mm (D)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INTAI Technology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000001158</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20020</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:21:33.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874673765</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure E-System Cortical Drill, F 5 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INTAI Technology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000001158</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20013</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:21:32.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874673758</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure E-System Cortical Drill, F 4.5 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INTAI Technology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000001158</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20012</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:21:31.241Z</lastUpdated>
  </row>
</eudamedExport>