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    <basicUdiDi>5903111FLATFEETSG</basicUdiDi>
    <tradeName>Vaya Deluxum 39</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VAYA Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000034726</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y061203</emdnCode>
    <emdnDescription>ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VAYA-ORT-101-39</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:25:04.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904473790336</udiDi>
    <basicUdiDi>5903111FLATFEETSG</basicUdiDi>
    <tradeName>Vaya Deluxum 40</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VAYA Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000034726</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y061203</emdnCode>
    <emdnDescription>ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VAYA-ORT-101-40</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:25:04.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904473790343</udiDi>
    <basicUdiDi>5903111FLATFEETSG</basicUdiDi>
    <tradeName>Vaya Deluxum 41</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VAYA Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000034726</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y061203</emdnCode>
    <emdnDescription>ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VAYA-ORT-101-41</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:25:04.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200913879</udiDi>
    <basicUdiDi>697590932NiTiRotary96</basicUdiDi>
    <tradeName>MT Files</tradeName>
    <deviceName>Dental Root-Canal Instruments</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 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>Z490 201 945 3104 025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:24:20.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200913862</udiDi>
    <basicUdiDi>697590932NiTiRotary96</basicUdiDi>
    <tradeName>MT Files</tradeName>
    <deviceName>Dental Root-Canal Instruments</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 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>Z490 201 945 3104 025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:24:19.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200913855</udiDi>
    <basicUdiDi>697590932NiTiRotary96</basicUdiDi>
    <tradeName>MT Files</tradeName>
    <deviceName>Dental Root-Canal Instruments</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 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>Z490 201 945 2504 025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:24:18.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200913848</udiDi>
    <basicUdiDi>697590932NiTiRotary96</basicUdiDi>
    <tradeName>MT Files</tradeName>
    <deviceName>Dental Root-Canal Instruments</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 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>Z490 201 945 2504 025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:24:15.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200913831</udiDi>
    <basicUdiDi>697590932NiTiRotary96</basicUdiDi>
    <tradeName>MT Files</tradeName>
    <deviceName>Dental Root-Canal Instruments</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 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>Z490 201 945 2104 025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:24:09.608Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200913824</udiDi>
    <basicUdiDi>697590932NiTiRotary96</basicUdiDi>
    <tradeName>MT Files</tradeName>
    <deviceName>Dental Root-Canal Instruments</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 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>Z490 201 945 2104 025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:24:08.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200913817</udiDi>
    <basicUdiDi>697590932NiTiRotary96</basicUdiDi>
    <tradeName>MT Files</tradeName>
    <deviceName>Dental Root-Canal Instruments</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 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>Z490 201 945 3104 020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:24:07.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200913800</udiDi>
    <basicUdiDi>697590932NiTiRotary96</basicUdiDi>
    <tradeName>MT Files</tradeName>
    <deviceName>Dental Root-Canal Instruments</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 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>Z490 201 945 3104 020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:24:06.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200913794</udiDi>
    <basicUdiDi>697590932NiTiRotary96</basicUdiDi>
    <tradeName>MT Files</tradeName>
    <deviceName>Dental Root-Canal Instruments</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 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>Z490 201 945 2504 020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:24:00.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200913787</udiDi>
    <basicUdiDi>697590932NiTiRotary96</basicUdiDi>
    <tradeName>MT Files</tradeName>
    <deviceName>Dental Root-Canal Instruments</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 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>Z490 201 945 2504 020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:23:57.604Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200913770</udiDi>
    <basicUdiDi>697590932NiTiRotary96</basicUdiDi>
    <tradeName>MT Files</tradeName>
    <deviceName>Dental Root-Canal Instruments</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 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>Z490 201 945 2104 020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:23:56.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200913763</udiDi>
    <basicUdiDi>697590932NiTiRotary96</basicUdiDi>
    <tradeName>MT Files</tradeName>
    <deviceName>Dental Root-Canal Instruments</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 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>Z490 201 945 2104 020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:23:55.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200913756</udiDi>
    <basicUdiDi>697590932NiTiRotary96</basicUdiDi>
    <tradeName>MT Files</tradeName>
    <deviceName>Dental Root-Canal Instruments</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 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>Z490 201 945 3104 015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:23:49.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200913749</udiDi>
    <basicUdiDi>697590932NiTiRotary96</basicUdiDi>
    <tradeName>MT Files</tradeName>
    <deviceName>Dental Root-Canal Instruments</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 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>Z490 201 945 3104 015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:23:47.988Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200913732</udiDi>
    <basicUdiDi>697590932NiTiRotary96</basicUdiDi>
    <tradeName>MT Files</tradeName>
    <deviceName>Dental Root-Canal Instruments</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 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>Z490 201 945 2504 015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:23:46.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200913725</udiDi>
    <basicUdiDi>697590932NiTiRotary96</basicUdiDi>
    <tradeName>MT Files</tradeName>
    <deviceName>Dental Root-Canal Instruments</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 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>Z490 201 945 2504 015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:23:45.583Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200913718</udiDi>
    <basicUdiDi>697590932NiTiRotary96</basicUdiDi>
    <tradeName>MT Files</tradeName>
    <deviceName>Dental Root-Canal Instruments</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 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>Z490 201 945 2104 015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T08:23:38.405Z</lastUpdated>
  </row>
</eudamedExport>