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    <manufacturerName>Shenzhen FeiHuan Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041454</manufacturerSrn>
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    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>#80</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:24.716Z</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>
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    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>#45、#50、#55、#60、#70、#80</reference>
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    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen FeiHuan Medical Instruments Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>#08、#10、#15</reference>
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    <lastUpdated>2026-09-23T13:35:24.632Z</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>#06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:24.586Z</lastUpdated>
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    <udiDi>06941576132020</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</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:24.560Z</lastUpdated>
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    <udiDi>06941576132037</udiDi>
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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>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>#10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:24.534Z</lastUpdated>
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    <udiDi>06941576132044</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</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:24.505Z</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>#20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:24.476Z</lastUpdated>
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    <udiDi>06941576132068</udiDi>
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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>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>#25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:24.447Z</lastUpdated>
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    <udiDi>06941576132075</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>#30</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:24.409Z</lastUpdated>
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    <udiDi>06941576132082</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>#35</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:24.375Z</lastUpdated>
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    <udiDi>06941576132099</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>#40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:24.342Z</lastUpdated>
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    <udiDi>06941576132105</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>2026-09-23T13:35:24.268Z</lastUpdated>
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    <udiDi>06941576132112</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>2026-09-23T13:35:24.230Z</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>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>#55</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:24.193Z</lastUpdated>
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    <udiDi>06941576132136</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>2026-09-23T13:35:24.157Z</lastUpdated>
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    <udiDi>06941576132143</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>2026-09-23T13:35:24.119Z</lastUpdated>
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    <udiDi>06941576132150</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>2026-09-23T13:35:24.092Z</lastUpdated>
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    <udiDi>06941576109701</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>2026-09-23T13:35:24.061Z</lastUpdated>
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    <udiDi>06941576132327</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>2026-09-23T13:35:24.029Z</lastUpdated>
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