<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06941576131566</udiDi>
    <basicUdiDi>69415761HandfilesK2</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen FeiHuan Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041454</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>#15、#20、#25、#30、#35、#40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:34.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576131504</udiDi>
    <basicUdiDi>69415761HandfilesK2</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen FeiHuan Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041454</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>#45</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:34.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576131511</udiDi>
    <basicUdiDi>69415761HandfilesK2</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen FeiHuan Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041454</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>#50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:34.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576131528</udiDi>
    <basicUdiDi>69415761HandfilesK2</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen FeiHuan Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041454</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>#55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:33.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576131535</udiDi>
    <basicUdiDi>69415761HandfilesK2</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen FeiHuan Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041454</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>#60</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:33.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576131542</udiDi>
    <basicUdiDi>69415761HandfilesK2</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen FeiHuan Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041454</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>#70</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:33.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576131559</udiDi>
    <basicUdiDi>69415761HandfilesK2</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen FeiHuan Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041454</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>#80</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:33.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576131573</udiDi>
    <basicUdiDi>69415761HandfilesK2</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen FeiHuan Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041454</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>#45、#50、#55、#60、#70、#80</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:33.848Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576131610</udiDi>
    <basicUdiDi>69415761HandfilesK2</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen FeiHuan Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041454</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>#06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:33.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576131702</udiDi>
    <basicUdiDi>69415761HandfilesK2</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen FeiHuan Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041454</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>#45</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:33.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576131719</udiDi>
    <basicUdiDi>69415761HandfilesK2</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen FeiHuan Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041454</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>#50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:33.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576131726</udiDi>
    <basicUdiDi>69415761HandfilesK2</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen FeiHuan Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041454</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>#55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:33.715Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576131733</udiDi>
    <basicUdiDi>69415761HandfilesK2</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen FeiHuan Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041454</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>#60</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:33.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576131740</udiDi>
    <basicUdiDi>69415761HandfilesK2</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen FeiHuan Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041454</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>#70</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:33.653Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576131757</udiDi>
    <basicUdiDi>69415761HandfilesK2</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen FeiHuan Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041454</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>#80</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:33.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576105970</udiDi>
    <basicUdiDi>69415761HandfilesK2</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen FeiHuan Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041454</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>#08、#10、#15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:33.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576103884</udiDi>
    <basicUdiDi>69415761HandfilesK2</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen FeiHuan Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041454</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>#08、#10、#15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:33.551Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576104195</udiDi>
    <basicUdiDi>69415761HandfilesK2</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen FeiHuan Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041454</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>#08、#10、#15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:33.524Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576104317</udiDi>
    <basicUdiDi>69415761HandfilesK2</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen FeiHuan Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041454</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>#12</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:33.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576106830</udiDi>
    <basicUdiDi>69415761HandfilesK2</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen FeiHuan Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041454</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>#08、#10、#15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:33.455Z</lastUpdated>
  </row>
</eudamedExport>