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    <manufacturerName>Zhejiang Shinye Medical Technology Corp. , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023934</manufacturerSrn>
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    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
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    <reference>4P19</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:37:07.743Z</lastUpdated>
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    <deviceName>Bands</deviceName>
    <manufacturerName>Zhejiang Shinye Medical Technology Corp. , Ltd.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-29T23:31:55.977Z</lastUpdated>
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    <deviceName>Bands</deviceName>
    <manufacturerName>Zhejiang Shinye Medical Technology Corp. , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023934</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>5001-000-09</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T23:31:54.768Z</lastUpdated>
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    <tradeName>i-shinye</tradeName>
    <deviceName>Invisible aligners appliance</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>MDR 2017/745</legislation>
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    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9201</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T23:31:53.557Z</lastUpdated>
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    <basicUdiDi>697039438101KJ</basicUdiDi>
    <tradeName>Lingual Buttons</tradeName>
    <deviceName>Lingual Buttons</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>MDR 2017/745</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9131-2A1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T23:31:47.581Z</lastUpdated>
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    <udiDi>06970394382584</udiDi>
    <basicUdiDi>697039438109L2</basicUdiDi>
    <tradeName>Crimpable Hooks</tradeName>
    <deviceName>Crimpable Hooks</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>MDR 2017/745</legislation>
    <emdnCode>Q010404</emdnCode>
    <emdnDescription>ORTHODONTIC ELASTICS, CHAINS AND SPRINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9121-221</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T23:31:46.398Z</lastUpdated>
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    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8116-10B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:13:51.714Z</lastUpdated>
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    <tradeName>Orthodontic Stainless Steel Wires</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3512-1925</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:13:51.680Z</lastUpdated>
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    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6115</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:13:51.651Z</lastUpdated>
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    <udiDi>06942054758053</udiDi>
    <basicUdiDi>69420547004SF</basicUdiDi>
    <tradeName>Ceramic Brackets</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>821H-23N</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:13:51.622Z</lastUpdated>
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    <basicUdiDi>69420547104SL</basicUdiDi>
    <tradeName>Orthodontic Springs</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC ELASTICS, CHAINS AND SPRINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9101-206</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:13:51.601Z</lastUpdated>
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    <basicUdiDi>69420547201SK</basicUdiDi>
    <tradeName>Lip Retractors</tradeName>
    <deviceName></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 I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7101-101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:13:51.562Z</lastUpdated>
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    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>103</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:13:51.529Z</lastUpdated>
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    <basicUdiDi>697039438100KG</basicUdiDi>
    <tradeName>Orthodontic Elastomeric Accessories</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC ELASTICS, CHAINS AND SPRINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91B3-01A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:13:51.494Z</lastUpdated>
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    <tradeName>Self-ligating Brackets</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>83N1-23E-A4</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:13:51.454Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Zhejiang Shinye Medical Technology Corp. , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023934</manufacturerSrn>
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    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8115-10B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:13:51.421Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Zhejiang Shinye Medical Technology Corp. , Ltd.</manufacturerName>
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    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8115-13B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:13:51.392Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Zhejiang Shinye Medical Technology Corp. , Ltd.</manufacturerName>
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    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8115-15B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:13:51.360Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Zhejiang Shinye Medical Technology Corp. , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023934</manufacturerSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8117-10B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:13:51.333Z</lastUpdated>
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    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8117-15B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T15:13:51.301Z</lastUpdated>
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