<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06942200953424</udiDi>
    <basicUdiDi>697590932NiTiHandfilesYZ</basicUdiDi>
    <tradeName>TG6(hand)</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>V497 650 922 2107 020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:51:54.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200953431</udiDi>
    <basicUdiDi>697590932NiTiHandfilesYZ</basicUdiDi>
    <tradeName>TG6(hand)</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>V497 650 922 2107 020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:51:54.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200953448</udiDi>
    <basicUdiDi>697590932NiTiHandfilesYZ</basicUdiDi>
    <tradeName>TG6(hand)</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>V497 650 922 2507 020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:51:54.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200953455</udiDi>
    <basicUdiDi>697590932NiTiHandfilesYZ</basicUdiDi>
    <tradeName>TG6(hand)</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>V497 650 922 2507 020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:51:54.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200953462</udiDi>
    <basicUdiDi>697590932NiTiHandfilesYZ</basicUdiDi>
    <tradeName>TG6(hand)</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>V497 650 922 3107 020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:51:54.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200953479</udiDi>
    <basicUdiDi>697590932NiTiHandfilesYZ</basicUdiDi>
    <tradeName>TG6(hand)</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>V497 650 922 3107 020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:51:45.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200953486</udiDi>
    <basicUdiDi>697590932NiTiHandfilesYZ</basicUdiDi>
    <tradeName>TG6(hand)</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>V497 650 922 2108 025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:51:45.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200953493</udiDi>
    <basicUdiDi>697590932NiTiHandfilesYZ</basicUdiDi>
    <tradeName>TG6(hand)</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>V497 650 922 2108 025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:51:45.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200953509</udiDi>
    <basicUdiDi>697590932NiTiHandfilesYZ</basicUdiDi>
    <tradeName>TG6(hand)</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>V497 650 922 2508 025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:51:45.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200953516</udiDi>
    <basicUdiDi>697590932NiTiHandfilesYZ</basicUdiDi>
    <tradeName>TG6(hand)</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>V497 650 922 2508 025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:51:45.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200953523</udiDi>
    <basicUdiDi>697590932NiTiHandfilesYZ</basicUdiDi>
    <tradeName>TG6(hand)</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>V497 650 922 3108 025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:51:45.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200953530</udiDi>
    <basicUdiDi>697590932NiTiHandfilesYZ</basicUdiDi>
    <tradeName>TG6(hand)</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>V497 650 922 3108 025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:51:45.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200953547</udiDi>
    <basicUdiDi>697590932NiTiHandfilesYZ</basicUdiDi>
    <tradeName>TG6(hand)</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>V497 650 922 2109 030</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:51:45.382Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200953554</udiDi>
    <basicUdiDi>697590932NiTiHandfilesYZ</basicUdiDi>
    <tradeName>TG6(hand)</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>V497 650 922 2109 030</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:51:45.366Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200954759</udiDi>
    <basicUdiDi>697590932SSTCompactorS9</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>J330 650 982 3102 025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:51:45.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200954766</udiDi>
    <basicUdiDi>697590932SSTCompactorS9</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>J330 650 982 2102 030</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:51:45.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200954773</udiDi>
    <basicUdiDi>697590932SSTCompactorS9</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>J330 650 982 2102 030</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:51:45.301Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200954780</udiDi>
    <basicUdiDi>697590932SSTCompactorS9</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>J330 650 982 2502 030</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:51:45.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200954797</udiDi>
    <basicUdiDi>697590932SSTCompactorS9</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>J330 650 982 2502 030</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:51:45.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200954803</udiDi>
    <basicUdiDi>697590932SSTCompactorS9</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>J330 650 982 2802 030</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:51:45.248Z</lastUpdated>
  </row>
</eudamedExport>