<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06972842346162</udiDi>
    <basicUdiDi>697284234RCF01KF</basicUdiDi>
    <tradeName>06972842346162</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jining Orodeka Medical Equipment CO; LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000034133</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-file015# 25mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:30:31.881Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972842346179</udiDi>
    <basicUdiDi>697284234RCF01KF</basicUdiDi>
    <tradeName>06972842346179</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jining Orodeka Medical Equipment CO; LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000034133</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-file015# 28mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:30:31.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972842346186</udiDi>
    <basicUdiDi>697284234RCF01KF</basicUdiDi>
    <tradeName>06972842346186</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jining Orodeka Medical Equipment CO; LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000034133</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-file015# 31mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:30:31.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972842346193</udiDi>
    <basicUdiDi>697284234RCF01KF</basicUdiDi>
    <tradeName>06972842346193</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jining Orodeka Medical Equipment CO; LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000034133</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-file020# 21mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:30:31.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972842346209</udiDi>
    <basicUdiDi>697284234RCF01KF</basicUdiDi>
    <tradeName>06972842346209</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jining Orodeka Medical Equipment CO; LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000034133</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-file020# 25mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:30:31.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972842346216</udiDi>
    <basicUdiDi>697284234RCF01KF</basicUdiDi>
    <tradeName>06972842346216</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jining Orodeka Medical Equipment CO; LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000034133</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-file020# 28mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:30:31.807Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972842346223</udiDi>
    <basicUdiDi>697284234RCF01KF</basicUdiDi>
    <tradeName>06972842346223</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jining Orodeka Medical Equipment CO; LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000034133</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-file020# 31mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:30:31.797Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972842346230</udiDi>
    <basicUdiDi>697284234RCF01KF</basicUdiDi>
    <tradeName>06972842346230</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jining Orodeka Medical Equipment CO; LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000034133</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-file025# 21mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:30:31.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972842346247</udiDi>
    <basicUdiDi>697284234RCF01KF</basicUdiDi>
    <tradeName>06972842346247</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jining Orodeka Medical Equipment CO; LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000034133</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-file025# 25mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:30:31.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972842346254</udiDi>
    <basicUdiDi>697284234RCF01KF</basicUdiDi>
    <tradeName>06972842346254</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jining Orodeka Medical Equipment CO; LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000034133</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-file025# 28mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:30:31.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972842346261</udiDi>
    <basicUdiDi>697284234RCF01KF</basicUdiDi>
    <tradeName>06972842346261</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jining Orodeka Medical Equipment CO; LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000034133</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-file025# 31mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:30:31.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972842346278</udiDi>
    <basicUdiDi>697284234RCF01KF</basicUdiDi>
    <tradeName>06972842346278</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jining Orodeka Medical Equipment CO; LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000034133</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-file030# 21mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:30:31.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972842346285</udiDi>
    <basicUdiDi>697284234RCF01KF</basicUdiDi>
    <tradeName>06972842346285</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jining Orodeka Medical Equipment CO; LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000034133</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-file030# 25mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:30:31.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972842346292</udiDi>
    <basicUdiDi>697284234RCF01KF</basicUdiDi>
    <tradeName>06972842346292</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jining Orodeka Medical Equipment CO; LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000034133</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-file030# 28mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:30:31.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972842346308</udiDi>
    <basicUdiDi>697284234RCF01KF</basicUdiDi>
    <tradeName>06972842346308</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jining Orodeka Medical Equipment CO; LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000034133</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-file030# 31mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:30:31.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972842346315</udiDi>
    <basicUdiDi>697284234RCF01KF</basicUdiDi>
    <tradeName>06972842346315</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jining Orodeka Medical Equipment CO; LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000034133</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-file035# 21mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:30:31.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972842346322</udiDi>
    <basicUdiDi>697284234RCF01KF</basicUdiDi>
    <tradeName>06972842346322</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jining Orodeka Medical Equipment CO; LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000034133</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-file035# 25mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:30:31.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972842346339</udiDi>
    <basicUdiDi>697284234RCF01KF</basicUdiDi>
    <tradeName>06972842346339</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jining Orodeka Medical Equipment CO; LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000034133</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-file035# 28mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:30:31.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972842346346</udiDi>
    <basicUdiDi>697284234RCF01KF</basicUdiDi>
    <tradeName>06972842346346</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jining Orodeka Medical Equipment CO; LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000034133</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-file035# 31mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:30:31.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972842346353</udiDi>
    <basicUdiDi>697284234RCF01KF</basicUdiDi>
    <tradeName>06972842346353</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jining Orodeka Medical Equipment CO; LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000034133</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-file040# 21mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:30:31.620Z</lastUpdated>
  </row>
</eudamedExport>