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    <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>#80</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:21.887Z</lastUpdated>
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    <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>
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    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>#60</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:21.836Z</lastUpdated>
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    <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>#45、#50、#55、#60、#70、#80</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:21.793Z</lastUpdated>
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    <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>2026-09-23T13:35:21.766Z</lastUpdated>
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  <row>
    <udiDi>06941576113425</udiDi>
    <basicUdiDi>69415761NiTiHandfiles78</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>#08</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:21.731Z</lastUpdated>
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    <udiDi>06941576132754</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>2026-09-23T13:35:21.704Z</lastUpdated>
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    <udiDi>06941576109732</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>2026-09-23T13:35:21.675Z</lastUpdated>
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  <row>
    <udiDi>06941576113432</udiDi>
    <basicUdiDi>69415761NiTiHandfiles78</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</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:21.642Z</lastUpdated>
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    <udiDi>06941576112022</udiDi>
    <basicUdiDi>69415761NiTiHandfiles78</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>#08</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:21.606Z</lastUpdated>
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    <udiDi>06941576113449</udiDi>
    <basicUdiDi>69415761NiTiHandfiles78</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>#15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:21.574Z</lastUpdated>
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  <row>
    <udiDi>06941576112039</udiDi>
    <basicUdiDi>69415761NiTiHandfiles78</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</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:21.536Z</lastUpdated>
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  <row>
    <udiDi>06941576113456</udiDi>
    <basicUdiDi>69415761NiTiHandfiles78</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</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:21.496Z</lastUpdated>
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  <row>
    <udiDi>06941576112046</udiDi>
    <basicUdiDi>69415761NiTiHandfiles78</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>#15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:21.437Z</lastUpdated>
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  <row>
    <udiDi>06941576113463</udiDi>
    <basicUdiDi>69415761NiTiHandfiles78</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</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:21.389Z</lastUpdated>
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    <udiDi>06941576112053</udiDi>
    <basicUdiDi>69415761NiTiHandfiles78</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</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:21.330Z</lastUpdated>
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    <udiDi>06941576113470</udiDi>
    <basicUdiDi>69415761NiTiHandfiles78</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</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:21.281Z</lastUpdated>
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    <udiDi>06941576112060</udiDi>
    <basicUdiDi>69415761NiTiHandfiles78</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</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:21.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576113487</udiDi>
    <basicUdiDi>69415761NiTiHandfiles78</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</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:21.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576112077</udiDi>
    <basicUdiDi>69415761NiTiHandfiles78</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</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:21.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941576113494</udiDi>
    <basicUdiDi>69415761NiTiHandfiles78</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</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:21.084Z</lastUpdated>
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