<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06936340025080</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Wave One GOLD</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>PPS Large</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:08:48.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340025073</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Wave One GOLD</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>PPS Medium</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:08:47.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340025066</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Wave One GOLD</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>PPS Medium</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:08:46.201Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340025059</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Wave One GOLD</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>PPS Primary</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:08:44.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340025042</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Wave One GOLD</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>PPS Primary</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:08:43.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340025035</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Wave One GOLD</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>PPS Small</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:08:42.601Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340025028</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Wave One GOLD</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>PPS Small</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:08:41.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340024953</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Protaper Type</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>PPS F5</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:08:40.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340024946</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Protaper Type</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>PPS F5</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:08:39.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340024939</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Protaper Type</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>PPS F4</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:08:37.806Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340024922</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Protaper Type</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>PPS F4</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:08:36.582Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340024915</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Protaper Type</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>PPS F3</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:08:35.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340024908</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Protaper Type</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>PPS F3</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:08:34.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340024892</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Protaper Type</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>PPS F2</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:08:33.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340024885</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Protaper Type</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>PPS F2</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:08:31.785Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340024878</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Protaper Type</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>PPS F1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:08:30.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340024861</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Protaper Type</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>PPS F1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:08:29.379Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340024779</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Accessory Type</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>PPS 024 54</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:08:28.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340024762</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Accessory Type</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>PPS 024 54</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:08:26.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340024755</udiDi>
    <basicUdiDi>69363400APP001F5</basicUdiDi>
    <tradeName>Variable taper points-Accessory Type</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>PPS 023 41</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:08:25.783Z</lastUpdated>
  </row>
</eudamedExport>