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<eudamedExport entity="devices">
  <row>
    <udiDi>04719874672430</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure C &amp; E System Twist Drill, 2 mm (D) x 11.5 mm (L), 12.5 mm Drill Length</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></emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK00062</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:08.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874672447</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure C &amp; E System Twist Drill, 2 mm (D) x 13 mm (L), 14 mm Drill Length</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></emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK00063</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:08.822Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874672454</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure C &amp; E System Twist Drill, 2 mm (D) x 15 mm (L), 16 mm Drill Length</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></emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK00064</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:08.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874672461</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>C-System Twist Step Drill, 2.4-2.8 mm (D) x 8.5-15 mm (L)</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></emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK10002</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:08.775Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874672478</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure C-System Twist Step Drill, 2.8-3.2 mm (D) x 8.5-15 mm (L)</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></emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK10003</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:08.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874672485</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure C-System Twist Step Drill, 3.2-3.6 mm (D) x 8.5-15 mm (L)</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></emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK10004</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:08.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874672492</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure C-System Twist Step Drill, 3.6-4.2 mm (D) x 8.5-15 mm (L)</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></emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK10005</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:08.697Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874672508</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure Twist Step Drill, 4.2-4.6 mm (D) x 8.5-15 mm (L)</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></emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK10006</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:08.672Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874672560</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure C-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></emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK10015</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:08.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874672577</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure C-system Implant tap, 4.3 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></emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK10016</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:08.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874672584</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure C-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></emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK10017</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:08.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874672591</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure C-system Implant tap, 3.9 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></emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK10038</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:08.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874672607</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure E-System Twist Drill, 3.3 mm (D) x 8.5-15 mm (L)</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></emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20002</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:08.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874672614</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure E-System Twist Drill, 4.3 mm (D) x 8.5-15 mm (L)</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></emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20003</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:08.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874672621</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>E-System Twist Drill, 3 mm (D) x 8.5-15 mm (L)</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></emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20004</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:08.498Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874672638</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure E-System Twist Drill, 3.8 mm (D) x 8.5-15 mm (L)</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></emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20005</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:08.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874672843</udiDi>
    <basicUdiDi>471987675DR0002F8</basicUdiDi>
    <tradeName>aZure Handpiece Implant Driver, Small, Short</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></emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK00065</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:08.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874672850</udiDi>
    <basicUdiDi>471987675DR0002F8</basicUdiDi>
    <tradeName>aZure Handpiece Implant Driver, Small, Long</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></emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK00066</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:08.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874672881</udiDi>
    <basicUdiDi>471987675DR0002F8</basicUdiDi>
    <tradeName>aZure Handpiece Implant Driver, Large, Short</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></emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK00069</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:08.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719874672898</udiDi>
    <basicUdiDi>471987675DR0002F8</basicUdiDi>
    <tradeName>aZure Handpiece Implant Driver, Large, Long</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></emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK00070</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:08.382Z</lastUpdated>
  </row>
</eudamedExport>