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    <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>035 002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:12.573Z</lastUpdated>
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    <udiDi>06942200960590</udiDi>
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    <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>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
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    <deviceName></deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
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    <reference>008 003</reference>
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    <udiDi>06942200960613</udiDi>
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    <tradeName>Micro Shaper</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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>010 003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:12.506Z</lastUpdated>
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    <udiDi>06942200960620</udiDi>
    <basicUdiDi>69422009MicroShaper59</basicUdiDi>
    <tradeName>Micro Shaper</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>015 002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:12.495Z</lastUpdated>
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    <udiDi>06942200960637</udiDi>
    <basicUdiDi>69422009MicroShaper59</basicUdiDi>
    <tradeName>Micro Shaper</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>020 002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:12.311Z</lastUpdated>
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    <udiDi>06942200960644</udiDi>
    <basicUdiDi>69422009MicroShaper59</basicUdiDi>
    <tradeName>Micro Shaper</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>025 002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:12.289Z</lastUpdated>
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    <udiDi>06942200960651</udiDi>
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    <tradeName>Micro Shaper</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>030 002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:12.264Z</lastUpdated>
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    <udiDi>06942200960668</udiDi>
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    <tradeName>Micro Shaper</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>035 002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:12.215Z</lastUpdated>
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    <udiDi>06942200960675</udiDi>
    <basicUdiDi>69422009MicroShaper59</basicUdiDi>
    <tradeName>Micro Shaper</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>040 002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:12.170Z</lastUpdated>
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    <udiDi>06942200960682</udiDi>
    <basicUdiDi>69422009MicroShaper59</basicUdiDi>
    <tradeName>Micro Shaper</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>010 004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:12.152Z</lastUpdated>
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    <udiDi>06942200960699</udiDi>
    <basicUdiDi>69422009MicroShaper59</basicUdiDi>
    <tradeName>Micro Shaper</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>010 006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:12.102Z</lastUpdated>
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    <udiDi>06942200960705</udiDi>
    <basicUdiDi>69422009MicroShaper59</basicUdiDi>
    <tradeName>Micro Shaper</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>015 004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:12.087Z</lastUpdated>
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    <udiDi>06942200900145</udiDi>
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    <tradeName>RT Scraper</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>Q010199</emdnCode>
    <emdnDescription>CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H-B、0.3S、0.5S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:12.052Z</lastUpdated>
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    <udiDi>06942200900589</udiDi>
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    <tradeName>RT Scraper</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:12.036Z</lastUpdated>
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    <udiDi>06942200900596</udiDi>
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    <tradeName>RT SCRAPER-Working Tip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <emdnCode>Q010199</emdnCode>
    <emdnDescription>CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0.3S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:11.988Z</lastUpdated>
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    <udiDi>06942200900602</udiDi>
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    <tradeName>RT SCRAPER-Working Tip</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>
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    <emdnCode>Q010199</emdnCode>
    <emdnDescription>CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0.3S-CR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:11.947Z</lastUpdated>
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    <tradeName>RT SCRAPER-Working Tip</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>Q010199</emdnCode>
    <emdnDescription>CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0.3S-CL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:11.936Z</lastUpdated>
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    <udiDi>06942200900626</udiDi>
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    <tradeName>RT SCRAPER-Working Tip</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>Q010199</emdnCode>
    <emdnDescription>CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0.5S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:11.923Z</lastUpdated>
  </row>
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    <udiDi>06942200900633</udiDi>
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    <tradeName>RT SCRAPER-Working Tip</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>Q010199</emdnCode>
    <emdnDescription>CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0.3L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:11.909Z</lastUpdated>
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