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    <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>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20011</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:21:30.328Z</lastUpdated>
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    <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>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20010</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:21:29.430Z</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>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20006</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:21:28.531Z</lastUpdated>
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    <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>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20042</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:21:27.631Z</lastUpdated>
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    <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>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20041</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:21:26.733Z</lastUpdated>
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    <udiDi>04719874673642</udiDi>
    <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>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20040</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:21:25.845Z</lastUpdated>
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    <udiDi>04719874673635</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure E-system Final Implant Drill, 5 mm (D) x 8.5 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>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20039</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:21:24.927Z</lastUpdated>
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    <udiDi>04719874673628</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure E-system Final Implant Drill, 4.5 mm (D) x 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>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20038</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:21:24.028Z</lastUpdated>
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    <udiDi>04719874673611</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure E-system Final Implant Drill, 4.5 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>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20037</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:21:23.132Z</lastUpdated>
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    <udiDi>04719874673604</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure E-system Final Implant Drill, 4.5 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>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20036</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:21:22.230Z</lastUpdated>
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    <udiDi>04719874673598</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure E-system Final Implant Drill, 4.5 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>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20035</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:21:21.329Z</lastUpdated>
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    <udiDi>04719874673581</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure E-system Final Implant Drill, 4.5 mm (D) x 8.5 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>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20034</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:21:20.451Z</lastUpdated>
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    <udiDi>04719874673574</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure E-system Final Implant Drill, 4 mm (D) x 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>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20033</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:21:19.527Z</lastUpdated>
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  <row>
    <udiDi>04719874673567</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure E-system Final Implant Drill, 4 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>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20032</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:21:18.628Z</lastUpdated>
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  <row>
    <udiDi>04719874673550</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure E-system Final Implant Drill, 4 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>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20031</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:21:17.730Z</lastUpdated>
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  <row>
    <udiDi>04719874673543</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure E-system Final Implant Drill, 4 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>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20030</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:21:16.832Z</lastUpdated>
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    <udiDi>04719874673536</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure E-system Final Implant Drill, 4 mm (D) x 8.5 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>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20029</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:21:15.930Z</lastUpdated>
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    <udiDi>04719874673529</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure E-system Final Implant Drill, 3.5 mm (D) x 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>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20028</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:21:15.046Z</lastUpdated>
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  <row>
    <udiDi>04719874673512</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure E-system Final Implant Drill, 3.5 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>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20027</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:21:14.143Z</lastUpdated>
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  <row>
    <udiDi>04719874673505</udiDi>
    <basicUdiDi>471987675DR0001F6</basicUdiDi>
    <tradeName>aZure E-system Final Implant Drill, 3.5 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>L99</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI0SK20026</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:21:13.232Z</lastUpdated>
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