<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06959074297141</udiDi>
    <basicUdiDi>69590742NiTiRotaryVR</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName>Dental Root-Canal Instruments</deviceName>
    <manufacturerName>Shenzhen Perfect Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025529</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>i File X GOLD,45/.04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:18:58.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959074297134</udiDi>
    <basicUdiDi>69590742NiTiRotaryVR</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName>Dental Root-Canal Instruments</deviceName>
    <manufacturerName>Shenzhen Perfect Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025529</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>i File X GOLD,40/.04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:18:55.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959074297127</udiDi>
    <basicUdiDi>69590742NiTiRotaryVR</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName>Dental Root-Canal Instruments</deviceName>
    <manufacturerName>Shenzhen Perfect Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025529</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>i File X GOLD,35/.04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:18:54.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959074297110</udiDi>
    <basicUdiDi>69590742NiTiRotaryVR</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName>Dental Root-Canal Instruments</deviceName>
    <manufacturerName>Shenzhen Perfect Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025529</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>i File X GOLD,30/.04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:18:48.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959074297103</udiDi>
    <basicUdiDi>69590742NiTiRotaryVR</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName>Dental Root-Canal Instruments</deviceName>
    <manufacturerName>Shenzhen Perfect Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025529</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>i File X GOLD,25/.04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:18:47.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959074297097</udiDi>
    <basicUdiDi>69590742NiTiRotaryVR</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName>Dental Root-Canal Instruments</deviceName>
    <manufacturerName>Shenzhen Perfect Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025529</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>i File X GOLD,20/.04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:18:46.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959074297080</udiDi>
    <basicUdiDi>69590742NiTiRotaryVR</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName>Dental Root-Canal Instruments</deviceName>
    <manufacturerName>Shenzhen Perfect Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025529</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>i File X GOLD,17/.06</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:18:45.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959074297073</udiDi>
    <basicUdiDi>69590742NiTiRotaryVR</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName>Dental Root-Canal Instruments</deviceName>
    <manufacturerName>Shenzhen Perfect Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025529</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>i File X GOLD,17/.06</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:18:37.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959074297066</udiDi>
    <basicUdiDi>69590742NiTiRotaryVR</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName>Dental Root-Canal Instruments</deviceName>
    <manufacturerName>Shenzhen Perfect Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025529</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>i File X GOLD,17/.06</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:18:36.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959074297059</udiDi>
    <basicUdiDi>69590742NiTiRotaryVR</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName>Dental Root-Canal Instruments</deviceName>
    <manufacturerName>Shenzhen Perfect Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025529</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>i File X GOLD,17/.04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:18:35.495Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959074297042</udiDi>
    <basicUdiDi>69590742NiTiRotaryVR</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName>Dental Root-Canal Instruments</deviceName>
    <manufacturerName>Shenzhen Perfect Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025529</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>i File X GOLD,17/.04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:18:34.270Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959074297035</udiDi>
    <basicUdiDi>69590742NiTiRotaryVR</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName>Dental Root-Canal Instruments</deviceName>
    <manufacturerName>Shenzhen Perfect Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025529</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>i File X GOLD,17/.04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:18:28.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959074297028</udiDi>
    <basicUdiDi>69590742HandfilesPT</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName>Dental Root-Canal Instruments</deviceName>
    <manufacturerName>Shenzhen Perfect Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025529</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSR,#15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:18:27.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959074297011</udiDi>
    <basicUdiDi>69590742HandfilesPT</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName>Dental Root-Canal Instruments</deviceName>
    <manufacturerName>Shenzhen Perfect Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025529</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSR,#08</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:18:25.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959074297004</udiDi>
    <basicUdiDi>69590742HandfilesPT</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName>Dental Root-Canal Instruments</deviceName>
    <manufacturerName>Shenzhen Perfect Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025529</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSH,#25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:18:24.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959074296991</udiDi>
    <basicUdiDi>69590742HandfilesPT</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName>Dental Root-Canal Instruments</deviceName>
    <manufacturerName>Shenzhen Perfect Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025529</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSH,#15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:18:17.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959074296984</udiDi>
    <basicUdiDi>69590742NiTiCompactorMW</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName>Dental Root-Canal Instruments</deviceName>
    <manufacturerName>Shenzhen Perfect Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025529</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSS,#15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:18:16.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959074296977</udiDi>
    <basicUdiDi>69590742NiTiCompactorMW</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName>Dental Root-Canal Instruments</deviceName>
    <manufacturerName>Shenzhen Perfect Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025529</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSS,#20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:18:15.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959074296960</udiDi>
    <basicUdiDi>69590742HandfilesPT</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName>Dental Root-Canal Instruments</deviceName>
    <manufacturerName>Shenzhen Perfect Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025529</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSK,#08</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:18:13.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959074296953</udiDi>
    <basicUdiDi>69590742HandfilesPT</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName>Dental Root-Canal Instruments</deviceName>
    <manufacturerName>Shenzhen Perfect Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025529</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSK,#20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:17:09.446Z</lastUpdated>
  </row>
</eudamedExport>