<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08586014625139</udiDi>
    <basicUdiDi>858601462000002KX</basicUdiDi>
    <tradeName>DK50 2V/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>403201051-301</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:40.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>08586014625153</udiDi>
    <basicUdiDi>858601462000002KX</basicUdiDi>
    <tradeName>DK50-10S/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>402102051-000</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:39.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>08586014625160</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>403202051-301</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:39.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>08586014625214</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>4032020A1-309</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:37.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>08586014625276</udiDi>
    <basicUdiDi>858601462000002KX</basicUdiDi>
    <tradeName>DK50</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>401402001-005</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:37.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>08586014625320</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>403D02001-313</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:37.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>08586014625337</udiDi>
    <basicUdiDi>858601462000002KX</basicUdiDi>
    <tradeName>DK50-10Z</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>402101001-310</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:34.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975702480143</udiDi>
    <basicUdiDi>697570248DC01HZ</basicUdiDi>
    <tradeName>06975702480143</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>06975702480143</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:23.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>08586014625344</udiDi>
    <basicUdiDi>858601462000002KX</basicUdiDi>
    <tradeName>DK50 4VR/50 S/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>4067021A5-102</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:23.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>08586014625368</udiDi>
    <basicUdiDi>858601462000002KX</basicUdiDi>
    <tradeName>DK50 2V/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>406201085-010</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:23.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975702480150</udiDi>
    <basicUdiDi>697570248DC01HZ</basicUdiDi>
    <tradeName>06975702480150</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>06975702480150</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:22.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975702480167</udiDi>
    <basicUdiDi>697570248DC01HZ</basicUdiDi>
    <tradeName>06975702480167</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>06975702480167</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:21.892Z</lastUpdated>
  </row>
  <row>
    <udiDi>08586014625405</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>403202081-004</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:20.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975702480174</udiDi>
    <basicUdiDi>697570248DC01HZ</basicUdiDi>
    <tradeName>06975702480174</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>06975702480174</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:19.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975702480181</udiDi>
    <basicUdiDi>697570248DC01HZ</basicUdiDi>
    <tradeName>06975702480181</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>06975702480181</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:05.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975702480198</udiDi>
    <basicUdiDi>697570248DC01HZ</basicUdiDi>
    <tradeName>06975702480198</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>06975702480198</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:04.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>08586014625412</udiDi>
    <basicUdiDi>858601462000002KX</basicUdiDi>
    <tradeName>DK50 2x2V/110S</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>404102006-406</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:03.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>08586014625429</udiDi>
    <basicUdiDi>858601462000002KX</basicUdiDi>
    <tradeName>DK50 2x2V/110S</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>404102006-411</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:01.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975702480204</udiDi>
    <basicUdiDi>697570248DC01HZ</basicUdiDi>
    <tradeName>06975702480204</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>06975702480204</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:51.298Z</lastUpdated>
  </row>
  <row>
    <udiDi>08586014625467</udiDi>
    <basicUdiDi>858601462000002KX</basicUdiDi>
    <tradeName>DK50-10S/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>402102051-001</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:50.298Z</lastUpdated>
  </row>
</eudamedExport>