<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06942200956166</udiDi>
    <basicUdiDi>697590932NiTiCompactor99</basicUdiDi>
    <tradeName>Spreaders</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J490 650 982 2802 035</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:09.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200956173</udiDi>
    <basicUdiDi>697590932NiTiCompactor99</basicUdiDi>
    <tradeName>Spreaders</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J490 650 982 2802 035</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:09.768Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200956180</udiDi>
    <basicUdiDi>697590932NiTiCompactor99</basicUdiDi>
    <tradeName>Spreaders</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J490 650 982 3102 035</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:09.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200956197</udiDi>
    <basicUdiDi>697590932NiTiCompactor99</basicUdiDi>
    <tradeName>Spreaders</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J490 650 982 3102 035</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:09.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200956203</udiDi>
    <basicUdiDi>697590932NiTiCompactor99</basicUdiDi>
    <tradeName>Spreaders</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J490 650 982 2102 040</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:09.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200956210</udiDi>
    <basicUdiDi>697590932NiTiCompactor99</basicUdiDi>
    <tradeName>Spreaders</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J490 650 982 2102 040</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:09.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200956227</udiDi>
    <basicUdiDi>697590932NiTiCompactor99</basicUdiDi>
    <tradeName>Spreaders</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J490 650 982 2502 040</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:09.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200956234</udiDi>
    <basicUdiDi>697590932NiTiCompactor99</basicUdiDi>
    <tradeName>Spreaders</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J490 650 982 2502 040</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:09.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200956241</udiDi>
    <basicUdiDi>697590932NiTiCompactor99</basicUdiDi>
    <tradeName>Spreaders</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J490 650 982 2802 040</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:09.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200956258</udiDi>
    <basicUdiDi>697590932NiTiCompactor99</basicUdiDi>
    <tradeName>Spreaders</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J490 650 982 2802 040</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:09.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200956265</udiDi>
    <basicUdiDi>697590932NiTiCompactor99</basicUdiDi>
    <tradeName>Spreaders</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J490 650 982 3102 040</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:09.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200956272</udiDi>
    <basicUdiDi>697590932NiTiCompactor99</basicUdiDi>
    <tradeName>Spreaders</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J490 650 982 3102 040</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:09.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200956289</udiDi>
    <basicUdiDi>697590932NiTiCompactor99</basicUdiDi>
    <tradeName>Spreaders</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J490 650 982 2102 045</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:09.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200956296</udiDi>
    <basicUdiDi>697590932NiTiCompactor99</basicUdiDi>
    <tradeName>Spreaders</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J490 650 982 2102 045</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:09.478Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200956302</udiDi>
    <basicUdiDi>697590932NiTiCompactor99</basicUdiDi>
    <tradeName>Spreaders</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J490 650 982 2502 045</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:09.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200956319</udiDi>
    <basicUdiDi>697590932NiTiCompactor99</basicUdiDi>
    <tradeName>Spreaders</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J490 650 982 2502 045</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:09.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200956326</udiDi>
    <basicUdiDi>697590932NiTiCompactor99</basicUdiDi>
    <tradeName>Spreaders</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J490 650 982 2802 045</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:09.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200956333</udiDi>
    <basicUdiDi>697590932NiTiCompactor99</basicUdiDi>
    <tradeName>Spreaders</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J490 650 982 2802 045</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:09.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200956340</udiDi>
    <basicUdiDi>697590932NiTiCompactor99</basicUdiDi>
    <tradeName>Spreaders</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J490 650 982 3102 045</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:09.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200956357</udiDi>
    <basicUdiDi>697590932NiTiCompactor99</basicUdiDi>
    <tradeName>Spreaders</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J490 650 982 3102 045</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:09.350Z</lastUpdated>
  </row>
</eudamedExport>