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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>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>2026-09-23T13:35:08.042Z</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>
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    <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>#30</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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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>
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    <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>2026-09-23T13:35:07.988Z</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>50/.06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:07.958Z</lastUpdated>
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    <udiDi>06941576137681</udiDi>
    <basicUdiDi>69415761NiTiCompactorFD</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>2026-09-23T13:35:07.935Z</lastUpdated>
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    <udiDi>06941576102269</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/.04、25/.06、30/.07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:07.896Z</lastUpdated>
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    <udiDi>06941576137698</udiDi>
    <basicUdiDi>69415761NiTiCompactorFD</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>2026-09-23T13:35:07.871Z</lastUpdated>
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  <row>
    <udiDi>06941576133287</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>2026-09-23T13:35:07.849Z</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>#40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:07.826Z</lastUpdated>
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  <row>
    <udiDi>06941576109695</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、50/.06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:07.799Z</lastUpdated>
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    <udiDi>06941576137766</udiDi>
    <basicUdiDi>69415761NiTiCompactorFD</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、#20、#25、#30、#35、#40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:07.772Z</lastUpdated>
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  <row>
    <udiDi>06941576102276</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/.07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:07.718Z</lastUpdated>
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  <row>
    <udiDi>06941576133362</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、#20、#25、#30、#35、#40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:07.694Z</lastUpdated>
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    <udiDi>06941576117041</udiDi>
    <basicUdiDi>69415761NiTiCompactorFD</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>2026-09-23T13:35:07.669Z</lastUpdated>
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    <udiDi>06941576102283</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>2026-09-23T13:35:07.645Z</lastUpdated>
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    <udiDi>06941576133300</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>#45</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:07.624Z</lastUpdated>
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    <udiDi>06941576117058</udiDi>
    <basicUdiDi>69415761NiTiCompactorFD</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>#20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:07.606Z</lastUpdated>
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  <row>
    <udiDi>06941576102290</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>2026-09-23T13:35:07.584Z</lastUpdated>
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  <row>
    <udiDi>06941576133317</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>2026-09-23T13:35:07.562Z</lastUpdated>
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  <row>
    <udiDi>06941576117065</udiDi>
    <basicUdiDi>69415761NiTiCompactorFD</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>#25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T13:35:07.504Z</lastUpdated>
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