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<eudamedExport entity="devices">
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    <udiDi>06975702480211</udiDi>
    <basicUdiDi>697570248DC01HZ</basicUdiDi>
    <tradeName>06975702480211</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dongguan Ouwen Medical Device Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013171</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06975702480211</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:47.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>08586014625528</udiDi>
    <basicUdiDi>858601462000002KX</basicUdiDi>
    <tradeName>DK50 PLUS/M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EKOM spol. s r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000002069</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4031010B1-404</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:47.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>00844868048510</udiDi>
    <basicUdiDi>844868A2GU</basicUdiDi>
    <tradeName>Immediate Molar Indicator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ZimVie US Corp LLC</manufacturerName>
    <manufacturerSrn>US-MF-000048255</manufacturerSrn>
    <authorisedRepresentativeName>ZimVie Spain S.L.U.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000983</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMDIR34</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:47.056Z</lastUpdated>
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  <row>
    <udiDi>08586014625559</udiDi>
    <basicUdiDi>858601462000002KX</basicUdiDi>
    <tradeName>DK50 2x4VR/110S/M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EKOM spol. s r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000002069</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4047121B6-003</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:46.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975702480228</udiDi>
    <basicUdiDi>697570248DC01HZ</basicUdiDi>
    <tradeName>06975702480228</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dongguan Ouwen Medical Device Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013171</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06975702480228</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:46.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>08586014625818</udiDi>
    <basicUdiDi>858601462000002KX</basicUdiDi>
    <tradeName>DK50 4VR/50/M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EKOM spol. s r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000002069</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4067011B5-102</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:37.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>08586014625566</udiDi>
    <basicUdiDi>858601462000002KX</basicUdiDi>
    <tradeName>DK50 2VS/M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EKOM spol. s r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000002069</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4032022A1-301</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:36.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975702480235</udiDi>
    <basicUdiDi>697570248DC01HZ</basicUdiDi>
    <tradeName>06975702480235</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dongguan Ouwen Medical Device Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013171</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06975702480235</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:35.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>08586014625573</udiDi>
    <basicUdiDi>858601462000002KX</basicUdiDi>
    <tradeName>DK50 2VS/M MOBILE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EKOM spol. s r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000002069</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4092020B5-305</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:35.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975702480242</udiDi>
    <basicUdiDi>697570248DC01HZ</basicUdiDi>
    <tradeName>06975702480242</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dongguan Ouwen Medical Device Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013171</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06975702480242</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:34.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975702480259</udiDi>
    <basicUdiDi>697570248DC01HZ</basicUdiDi>
    <tradeName>06975702480259</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dongguan Ouwen Medical Device Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013171</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06975702480259</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:33.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975702480266</udiDi>
    <basicUdiDi>697570248DC01HZ</basicUdiDi>
    <tradeName>06975702480266</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dongguan Ouwen Medical Device Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013171</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06975702480266</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:23.582Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975702480273</udiDi>
    <basicUdiDi>697570248DC01HZ</basicUdiDi>
    <tradeName>06975702480273</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dongguan Ouwen Medical Device Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013171</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06975702480273</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:07.583Z</lastUpdated>
  </row>
  <row>
    <udiDi>08586014625580</udiDi>
    <basicUdiDi>858601462000002KX</basicUdiDi>
    <tradeName>DK50 2V</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EKOM spol. s r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000002069</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>403201101-301</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:07.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>08586014625597</udiDi>
    <basicUdiDi>858601462000002KX</basicUdiDi>
    <tradeName>DK50 2VS/M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EKOM spol. s r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000002069</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4032020A5-307</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:05.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>08586014625603</udiDi>
    <basicUdiDi>858601462000002KX</basicUdiDi>
    <tradeName>DK50 PLUS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EKOM spol. s r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000002069</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>403C01005-415</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:40:42.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>08586014625610</udiDi>
    <basicUdiDi>858601462000002KX</basicUdiDi>
    <tradeName>DK50 PLUS S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EKOM spol. s r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000002069</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>403C02005-415</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:40:41.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>08586014625627</udiDi>
    <basicUdiDi>858601462000002KX</basicUdiDi>
    <tradeName>DK50 2V</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EKOM spol. s r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000002069</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>403D01005-311</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:40:40.828Z</lastUpdated>
  </row>
  <row>
    <udiDi>08586014625634</udiDi>
    <basicUdiDi>858601462000002KX</basicUdiDi>
    <tradeName>DK50 2VS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EKOM spol. s r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000002069</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>403D02005-311</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:40:40.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>08586014625658</udiDi>
    <basicUdiDi>858601462000002KX</basicUdiDi>
    <tradeName>DK50 2VS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EKOM spol. s r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000002069</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>403D02401-301</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:40:30.042Z</lastUpdated>
  </row>
</eudamedExport>