<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06975238156000</udiDi>
    <basicUdiDi>697523815BUCCALEUN</basicUdiDi>
    <tradeName>Denrotary</tradeName>
    <deviceName>Orthodontic Buccal Tubes</deviceName>
    <manufacturerName>Ningbo Denrotary Medical Apparatus Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042109</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BTEM226</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:30:11.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975238155003</udiDi>
    <basicUdiDi>697523815BKTENE</basicUdiDi>
    <tradeName>Denrotary</tradeName>
    <deviceName>Orthodontic Brackets</deviceName>
    <manufacturerName>Ningbo Denrotary Medical Apparatus Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042109</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BKEM180</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:30:10.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975238150503</udiDi>
    <basicUdiDi>697523815NITISEDSMS</basicUdiDi>
    <tradeName>Denrotary</tradeName>
    <deviceName>Orthodontic Wires</deviceName>
    <manufacturerName>Ningbo Denrotary Medical Apparatus Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042109</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NITISEDSU12</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:30:06.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975238150008</udiDi>
    <basicUdiDi>697523815LIGATUREFQ</basicUdiDi>
    <tradeName>Denrotary</tradeName>
    <deviceName>Orthodontic Elastomeric</deviceName>
    <manufacturerName>Ningbo Denrotary Medical Apparatus Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042109</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LT</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:30:05.905Z</lastUpdated>
  </row>
</eudamedExport>