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    <deviceName>bracket</deviceName>
    <manufacturerName>Zhejiang Shinye Medical Technology Corp. , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023934</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8354-11B-36</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:38:22.443Z</lastUpdated>
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    <deviceName>bracket</deviceName>
    <manufacturerName>Zhejiang Shinye Medical Technology Corp. , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023934</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:38:20.844Z</lastUpdated>
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    <deviceName>bracket</deviceName>
    <manufacturerName>Zhejiang Shinye Medical Technology Corp. , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023934</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:38:18.439Z</lastUpdated>
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    <deviceName>bracket</deviceName>
    <manufacturerName>Zhejiang Shinye Medical Technology Corp. , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023934</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8354-10B-46</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:38:16.838Z</lastUpdated>
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    <udiDi>06942054771304</udiDi>
    <basicUdiDi>B-06942054771304</basicUdiDi>
    <tradeName>06942054771304</tradeName>
    <deviceName>bracket</deviceName>
    <manufacturerName>Zhejiang Shinye Medical Technology Corp. , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023934</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8354-10B-36</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:38:16.044Z</lastUpdated>
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    <udiDi>06942054771298</udiDi>
    <basicUdiDi>B-06942054771298</basicUdiDi>
    <tradeName>06942054771298</tradeName>
    <deviceName>bracket</deviceName>
    <manufacturerName>Zhejiang Shinye Medical Technology Corp. , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023934</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8354-10B-26</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:38:14.439Z</lastUpdated>
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    <basicUdiDi>B-06942054771267</basicUdiDi>
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    <deviceName>bracket</deviceName>
    <manufacturerName>Zhejiang Shinye Medical Technology Corp. , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023934</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8353-11B-36</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:38:12.065Z</lastUpdated>
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    <basicUdiDi>B-06942054771281</basicUdiDi>
    <tradeName>06942054771281</tradeName>
    <deviceName>bracket</deviceName>
    <manufacturerName>Zhejiang Shinye Medical Technology Corp. , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023934</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8354-10B-16</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:38:10.439Z</lastUpdated>
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    <udiDi>06942054771274</udiDi>
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    <tradeName>06942054771274</tradeName>
    <deviceName>bracket</deviceName>
    <manufacturerName>Zhejiang Shinye Medical Technology Corp. , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023934</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8353-11B-46</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:38:09.636Z</lastUpdated>
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    <udiDi>06942054771250</udiDi>
    <basicUdiDi>B-06942054771250</basicUdiDi>
    <tradeName>06942054771250</tradeName>
    <deviceName>bracket</deviceName>
    <manufacturerName>Zhejiang Shinye Medical Technology Corp. , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023934</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8353-11B-26</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:38:08.032Z</lastUpdated>
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    <udiDi>06942054771243</udiDi>
    <basicUdiDi>B-06942054771243</basicUdiDi>
    <tradeName>06942054771243</tradeName>
    <deviceName>bracket</deviceName>
    <manufacturerName>Zhejiang Shinye Medical Technology Corp. , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023934</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8353-11B-16</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:37:52.777Z</lastUpdated>
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    <udiDi>06942054771236</udiDi>
    <basicUdiDi>B-06942054771236</basicUdiDi>
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    <deviceName>bracket</deviceName>
    <manufacturerName>Zhejiang Shinye Medical Technology Corp. , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023934</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8353-10B-46</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:37:51.976Z</lastUpdated>
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    <udiDi>06942054771229</udiDi>
    <basicUdiDi>B-06942054771229</basicUdiDi>
    <tradeName>06942054771229</tradeName>
    <deviceName>bracket</deviceName>
    <manufacturerName>Zhejiang Shinye Medical Technology Corp. , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023934</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8353-10B-36</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:37:51.181Z</lastUpdated>
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    <udiDi>06942054771212</udiDi>
    <basicUdiDi>B-06942054771212</basicUdiDi>
    <tradeName>06942054771212</tradeName>
    <deviceName>bracket</deviceName>
    <manufacturerName>Zhejiang Shinye Medical Technology Corp. , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023934</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8353-10B-26</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:37:47.177Z</lastUpdated>
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    <udiDi>06942054771205</udiDi>
    <basicUdiDi>B-06942054771205</basicUdiDi>
    <tradeName>06942054771205</tradeName>
    <deviceName>bracket</deviceName>
    <manufacturerName>Zhejiang Shinye Medical Technology Corp. , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023934</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8353-10B-16</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:37:46.382Z</lastUpdated>
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    <udiDi>06942054771199</udiDi>
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    <deviceName>bracket</deviceName>
    <manufacturerName>Zhejiang Shinye Medical Technology Corp. , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023934</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <emdnCode>Q010403</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>8354-11B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:37:45.611Z</lastUpdated>
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    <udiDi>06942054771182</udiDi>
    <basicUdiDi>B-06942054771182</basicUdiDi>
    <tradeName>06942054771182</tradeName>
    <deviceName>0.018 MBT* brackets Standard bondable Molar No hook, with laser mark</deviceName>
    <manufacturerName>Zhejiang Shinye Medical Technology Corp. , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023934</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8354-10B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:37:45.139Z</lastUpdated>
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    <deviceName>bracket</deviceName>
    <manufacturerName>Zhejiang Shinye Medical Technology Corp. , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023934</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>8353-11B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:37:40.806Z</lastUpdated>
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    <deviceName>bracket</deviceName>
    <manufacturerName>Zhejiang Shinye Medical Technology Corp. , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023934</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8353-10B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:37:39.983Z</lastUpdated>
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    <deviceName>bracket</deviceName>
    <manufacturerName>Zhejiang Shinye Medical Technology Corp. , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023934</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8378-15C</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:37:39.171Z</lastUpdated>
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