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    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure E-system Final Implant Drill, 5 mm (D) x 10 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>DI0SK20040</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:07.439Z</lastUpdated>
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  <row>
    <udiDi>04719874673659</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure E-system Final Implant Drill, 5 mm (D) x 11.5 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>DI0SK20041</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:07.412Z</lastUpdated>
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  <row>
    <udiDi>04719874673666</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure E-system Final Implant Drill, 5 mm (D) x 13 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>DI0SK20042</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:07.388Z</lastUpdated>
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    <udiDi>04719874673697</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure C &amp; E System Pilot Drill, 2-3 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>DI0SK20006</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:07.359Z</lastUpdated>
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  <row>
    <udiDi>04719874673734</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure E-System Cortical Drill, F 3.5 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></emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20010</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:07.334Z</lastUpdated>
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  <row>
    <udiDi>04719874673741</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure E-System Cortical Drill, F 4 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></emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20011</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:07.308Z</lastUpdated>
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  <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></emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20012</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:07.288Z</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></emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20013</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:07.262Z</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></emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20020</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:07.232Z</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></emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20021</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:07.204Z</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></emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20022</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:07.176Z</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></emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20023</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T11:08:07.145Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841210756</udiDi>
    <basicUdiDi>B-06936841210756</basicUdiDi>
    <tradeName>06936841210756</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tianck Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007451</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STOPCOCKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>081001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:58:22.327Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937017502101</udiDi>
    <basicUdiDi>697306977NitrileFR</basicUdiDi>
    <tradeName>SYNGUARD NITRILE EXAM GLOVES</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Anhui Intco Medical Products Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000002356</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SNBE10018</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:47:43.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937017502354</udiDi>
    <basicUdiDi>697306977NitrileFR</basicUdiDi>
    <tradeName>SYNGUARD NITRILE EXAM GLOVES</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Anhui Intco Medical Products Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000002356</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SNBE10043</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:47:43.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937017502361</udiDi>
    <basicUdiDi>697306977NitrileFR</basicUdiDi>
    <tradeName>SYNGUARD NITRILE EXAM GLOVES</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Anhui Intco Medical Products Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000002356</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SNBE10044</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:47:43.067Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937017502378</udiDi>
    <basicUdiDi>697306977NitrileFR</basicUdiDi>
    <tradeName>SYNGUARD NITRILE EXAM GLOVES</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Anhui Intco Medical Products Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000002356</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SNBE10045</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:47:43.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937017502385</udiDi>
    <basicUdiDi>697306977NitrileFR</basicUdiDi>
    <tradeName>SYNGUARD NITRILE EXAM GLOVES</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Anhui Intco Medical Products Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000002356</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SNBE10046</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:47:43.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937017502392</udiDi>
    <basicUdiDi>697306977NitrileFR</basicUdiDi>
    <tradeName>SYNGUARD NITRILE EXAM GLOVES</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Anhui Intco Medical Products Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000002356</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SNBE10047</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:47:42.986Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937017509254</udiDi>
    <basicUdiDi>697306977NitrileAFDY</basicUdiDi>
    <tradeName>Disposable Nitrile Gloves, Accelerator-Free, Powder Free</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Anhui Intco Medical Products Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000002356</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFBE10015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:47:42.949Z</lastUpdated>
  </row>
</eudamedExport>