<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>09120121910260</udiDi>
    <basicUdiDi>912012191FBANAVJ</basicUdiDi>
    <tradeName>Reference AB facebow junior</tradeName>
    <deviceName>GAMMA Facebow anatomisch</deviceName>
    <manufacturerName>"Gamma" Medizinisch-wissenschaftliche Fortbildungs GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000004222</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06-230430-J</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:41:00.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>09120121910123</udiDi>
    <basicUdiDi>912012191FBKINXF</basicUdiDi>
    <tradeName>Condylograph Facebow comfort</tradeName>
    <deviceName>GAMMA Facebow kinematisch</deviceName>
    <manufacturerName>"Gamma" Medizinisch-wissenschaftliche Fortbildungs GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000004222</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04-GCR007</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:40:54.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936463845503</udiDi>
    <basicUdiDi>697146493A5SR4</basicUdiDi>
    <tradeName>06936463845503</tradeName>
    <deviceName>Orthodontic traction device</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A51-20Lp</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:16:53.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971464931008</udiDi>
    <basicUdiDi>697146493A5SR4</basicUdiDi>
    <tradeName>06971464931008</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A51-10Sr</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:56:58.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971464931015</udiDi>
    <basicUdiDi>697146493A5SR4</basicUdiDi>
    <tradeName>06971464931015</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A51-12Lb</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:56:58.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971464931022</udiDi>
    <basicUdiDi>697146493A5SR4</basicUdiDi>
    <tradeName>06971464931022</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A51-12Lr</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:56:58.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971464931039</udiDi>
    <basicUdiDi>697146493A5SR4</basicUdiDi>
    <tradeName>06971464931039</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A51-12Mb</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:56:57.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971464931046</udiDi>
    <basicUdiDi>697146493A5SR4</basicUdiDi>
    <tradeName>06971464931046</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A51-12Sb</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:56:57.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971464931053</udiDi>
    <basicUdiDi>697146493A5SR4</basicUdiDi>
    <tradeName>06971464931053</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A51-12Sr</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:56:22.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971464931060</udiDi>
    <basicUdiDi>697146493A5SR4</basicUdiDi>
    <tradeName>06971464931060</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A51-20Lb</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:56:21.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971464931077</udiDi>
    <basicUdiDi>697146493A5SR4</basicUdiDi>
    <tradeName>06971464931077</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A51-20Lr</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:56:20.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971464931084</udiDi>
    <basicUdiDi>697146493A5SR4</basicUdiDi>
    <tradeName>06971464931084</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A51-20Sb</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:56:19.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971464931091</udiDi>
    <basicUdiDi>697146493A5SR4</basicUdiDi>
    <tradeName>06971464931091</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A51-20Sr</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:56:19.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971464931107</udiDi>
    <basicUdiDi>697146493A5SR4</basicUdiDi>
    <tradeName>06971464931107</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A51-21Sb</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:56:19.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971464931114</udiDi>
    <basicUdiDi>697146493A5SR4</basicUdiDi>
    <tradeName>06971464931114</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A51-22Lb</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:56:09.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936463845749</udiDi>
    <basicUdiDi>697146493A5SR4</basicUdiDi>
    <tradeName>06936463845749</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A51-22Pb</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:56:09.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971464931121</udiDi>
    <basicUdiDi>697146493A5SR4</basicUdiDi>
    <tradeName>06971464931121</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A51-22SB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:56:08.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971464931138</udiDi>
    <basicUdiDi>697146493A5SR4</basicUdiDi>
    <tradeName>06971464931138</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A52-10Lb</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:56:06.104Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971464931145</udiDi>
    <basicUdiDi>697146493A5SR4</basicUdiDi>
    <tradeName>06971464931145</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A52-10Lr</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:56:05.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971464931152</udiDi>
    <basicUdiDi>697146493A5SR4</basicUdiDi>
    <tradeName>06971464931152</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A52-10Sb</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:56:05.207Z</lastUpdated>
  </row>
</eudamedExport>