<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06941576107776</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、#08、#10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:34:34.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576115269</udiDi>
    <basicUdiDi>69415761NiTiRotaryQE</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>UNKNOWN</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50/.04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:34:34.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576108254</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>#90</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:34:34.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576115276</udiDi>
    <basicUdiDi>69415761NiTiRotaryQE</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>UNKNOWN</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60/.04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:34:34.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971745841231</udiDi>
    <basicUdiDi>69415761NiTiRotaryQE</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>UNKNOWN</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25/.06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:34:34.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576107660</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>#100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:34:34.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576115283</udiDi>
    <basicUdiDi>69415761NiTiRotaryQE</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>UNKNOWN</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25/.07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:34:34.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971745841248</udiDi>
    <basicUdiDi>69415761NiTiRotaryQE</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>UNKNOWN</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>35/.04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:34:34.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576108261</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>#110</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:34:34.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576115290</udiDi>
    <basicUdiDi>69415761NiTiRotaryQE</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>UNKNOWN</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30/.06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:34:34.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971745841255</udiDi>
    <basicUdiDi>69415761NiTiRotaryQE</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>UNKNOWN</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17/.10、20/.04、25/.06、35/.04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:34:34.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971745841262</udiDi>
    <basicUdiDi>69415761NiTiRotaryQE</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>UNKNOWN</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17/.10、15/.03、20/.04、25/.04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:34:34.076Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576115306</udiDi>
    <basicUdiDi>69415761NiTiRotaryQE</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>UNKNOWN</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>35/.06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:34:34.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576108278</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>#120</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:34:34.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971745847165</udiDi>
    <basicUdiDi>69415761NiTiRotaryQE</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>UNKNOWN</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17/.10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:34:34.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576115313</udiDi>
    <basicUdiDi>69415761NiTiRotaryQE</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>UNKNOWN</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40/.06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:34:33.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576108285</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>#130</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:34:33.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971745847172</udiDi>
    <basicUdiDi>69415761NiTiRotaryQE</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>UNKNOWN</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20/.04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:34:33.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576115320</udiDi>
    <basicUdiDi>69415761NiTiRotaryQE</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>UNKNOWN</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10/.04、15/.05、20/.06、25/.06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:34:33.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576107790</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、#08、#10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:34:33.858Z</lastUpdated>
  </row>
</eudamedExport>