<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06936340035010</udiDi>
    <basicUdiDi>69363400IB001E4</basicUdiDi>
    <tradeName>L-wire interdental brush</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q019003</emdnCode>
    <emdnDescription>DENTAL FLOSS AND OTHER DEVICES FOR ORAL HYGIENE (FOR PROFESSIONAL USE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSSS（0.4）</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:12:06.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340027251</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Next Type（Length Marked）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010401</emdnCode>
    <emdnDescription>PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PPK X5</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:12:04.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340027244</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Next Type（Length Marked）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010401</emdnCode>
    <emdnDescription>PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PPK X5</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:12:03.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340027237</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Next Type（Length Marked）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010401</emdnCode>
    <emdnDescription>PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PPK X4</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:12:01.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340027220</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Next Type（Length Marked）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010401</emdnCode>
    <emdnDescription>PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PPK X4</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:12:00.715Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340027213</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Next Type（Length Marked）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010401</emdnCode>
    <emdnDescription>PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PPK X3</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:59.626Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340027206</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Next Type（Length Marked）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010401</emdnCode>
    <emdnDescription>PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PPK X3</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:57.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340027190</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Next Type（Length Marked）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010401</emdnCode>
    <emdnDescription>PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PPK X2</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:55.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340027183</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Next Type（Length Marked）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010401</emdnCode>
    <emdnDescription>PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PPK X2</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:54.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340027176</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Next Type（Length Marked）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010401</emdnCode>
    <emdnDescription>PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PPK X1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:53.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340027169</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Next Type（Length Marked）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010401</emdnCode>
    <emdnDescription>PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PPK X1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:52.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340027138</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Reciproc Type（Length Marked）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010401</emdnCode>
    <emdnDescription>PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PPK R50</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:49.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340027121</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Reciproc Type（Length Marked）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010401</emdnCode>
    <emdnDescription>PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PPK R50</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:48.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340027114</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Reciproc Type（Length Marked）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010401</emdnCode>
    <emdnDescription>PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PPK R40</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:47.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340027107</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Reciproc Type（Length Marked）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010401</emdnCode>
    <emdnDescription>PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PPK R40</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:46.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340027091</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Reciproc Type（Length Marked）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010401</emdnCode>
    <emdnDescription>PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PPK R25</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:43.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340027084</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Reciproc Type（Length Marked）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010401</emdnCode>
    <emdnDescription>PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PPK R25</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:42.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340027053</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Wave One GOLD（Length Marked）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010401</emdnCode>
    <emdnDescription>PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PPK Large</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:41.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340027046</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Wave One GOLD（Length Marked）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010401</emdnCode>
    <emdnDescription>PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PPK Large</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:40.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340027039</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Wave One GOLD（Length Marked）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010401</emdnCode>
    <emdnDescription>PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PPK Medium</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:39.106Z</lastUpdated>
  </row>
</eudamedExport>