<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06936340027022</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>2026-06-24T13:11:37.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340027015</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 Primary</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:36.697Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340027008</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 Primary</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:35.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340026995</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 Small</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:34.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340026988</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 Small</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:33.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340026919</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Protaper 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 F5</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:31.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340026902</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Protaper 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 F5</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:30.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340026896</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Protaper 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 F4</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:28.298Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340026889</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Protaper 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 F4</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:27.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340026872</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Protaper 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 F3</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:25.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340026865</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Protaper 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 F3</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:24.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340026858</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Protaper 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 F2</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:23.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340026841</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Protaper 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 F2</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:22.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340026834</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Protaper 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 F1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:21.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340026827</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Protaper 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 F1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:19.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340026735</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Accessory 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 024 54</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:18.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340026728</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Accessory 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 024 54</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:17.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340026711</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Accessory 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 023 41</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:16.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340026704</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Accessory 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 023 41</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:15.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340026698</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Accessory 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 020 38</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:11:13.896Z</lastUpdated>
  </row>
</eudamedExport>