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    <tradeName>06977825542302</tradeName>
    <deviceName>Orthodontic tube</deviceName>
    <manufacturerName>Zhejiang Risheng Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011127</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TQM2-21270M</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:01:05.215Z</lastUpdated>
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  <row>
    <udiDi>06971464935594</udiDi>
    <basicUdiDi>697146493BM1RC</basicUdiDi>
    <tradeName>06971464935594</tradeName>
    <deviceName>orthodontic bracket</deviceName>
    <manufacturerName>Zhejiang Risheng Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011127</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>121</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:59:04.200Z</lastUpdated>
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    <udiDi>06936463800007</udiDi>
    <basicUdiDi>697146493BL2K</basicUdiDi>
    <tradeName>06936463800007</tradeName>
    <deviceName>Orthodontic bracket</deviceName>
    <manufacturerName>Zhejiang Risheng Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011127</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>SMD2-3407</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:54:29.499Z</lastUpdated>
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    <udiDi>06977825542449</udiDi>
    <basicUdiDi>697146493TS4P</basicUdiDi>
    <tradeName>06977825542449</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Risheng Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011127</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TQM2-21370M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:37:33.713Z</lastUpdated>
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  <row>
    <udiDi>06977825542609</udiDi>
    <basicUdiDi>697146493TS4P</basicUdiDi>
    <tradeName>06977825542609</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Risheng Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011127</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TQM2-21470M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:37:33.579Z</lastUpdated>
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    <udiDi>06936463844858</udiDi>
    <basicUdiDi>697146493BL2K</basicUdiDi>
    <tradeName>06936463844858</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Risheng Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011127</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMM1-0301</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:44:46.580Z</lastUpdated>
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  <row>
    <udiDi>06936463842595</udiDi>
    <basicUdiDi>697146493BL2K</basicUdiDi>
    <tradeName>06936463842595</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Risheng Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011127</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:44:45.387Z</lastUpdated>
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  <row>
    <udiDi>06936463838482</udiDi>
    <basicUdiDi>697146493BL2K</basicUdiDi>
    <tradeName>06936463838482</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Risheng Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011127</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMM1-0401</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:44:42.970Z</lastUpdated>
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    <udiDi>06936463838475</udiDi>
    <basicUdiDi>697146493BL2K</basicUdiDi>
    <tradeName>06936463838475</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Risheng Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011127</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMR2-0401</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:44:41.764Z</lastUpdated>
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  <row>
    <udiDi>06936463834002</udiDi>
    <basicUdiDi>697146493BL2K</basicUdiDi>
    <tradeName>06936463834002</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Risheng Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011127</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMM2-0401</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:44:40.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936463833999</udiDi>
    <basicUdiDi>697146493BL2K</basicUdiDi>
    <tradeName>06936463833999</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Risheng Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011127</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSR2-1145</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:44:39.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936463833982</udiDi>
    <basicUdiDi>697146493BL2K</basicUdiDi>
    <tradeName>06936463833982</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Risheng Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011127</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSR2-1125</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:44:36.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936463833975</udiDi>
    <basicUdiDi>697146493BL2K</basicUdiDi>
    <tradeName>06936463833975</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Risheng Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011127</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSR2-1123</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:44:35.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936463833968</udiDi>
    <basicUdiDi>697146493BL2K</basicUdiDi>
    <tradeName>06936463833968</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Risheng Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011127</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSR2-1022</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:44:34.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936463833951</udiDi>
    <basicUdiDi>697146493BL2K</basicUdiDi>
    <tradeName>06936463833951</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Risheng Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011127</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSR2-1021</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:44:33.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936463833944</udiDi>
    <basicUdiDi>697146493BL2K</basicUdiDi>
    <tradeName>06936463833944</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Risheng Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011127</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSR2-1115</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:44:32.162Z</lastUpdated>
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  <row>
    <udiDi>06936463833937</udiDi>
    <basicUdiDi>697146493BL2K</basicUdiDi>
    <tradeName>06936463833937</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Risheng Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011127</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSR2-1114</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:44:29.769Z</lastUpdated>
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  <row>
    <udiDi>06936463833920</udiDi>
    <basicUdiDi>697146493BL2K</basicUdiDi>
    <tradeName>06936463833920</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Risheng Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011127</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSR2-1113</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:44:28.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936463833913</udiDi>
    <basicUdiDi>697146493BL2K</basicUdiDi>
    <tradeName>06936463833913</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Risheng Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011127</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSR2-1012</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:44:27.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936463833906</udiDi>
    <basicUdiDi>697146493BL2K</basicUdiDi>
    <tradeName>06936463833906</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Risheng Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011127</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSR2-1011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:44:26.164Z</lastUpdated>
  </row>
</eudamedExport>