<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06954454002636</udiDi>
    <basicUdiDi>69544540PRCU001X3</basicUdiDi>
    <tradeName>Prophy Cup</tradeName>
    <deviceName>Prophy Cup</deviceName>
    <manufacturerName>Huanghua Promisee Dental Co.Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014766</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010502</emdnCode>
    <emdnDescription>DENTAL POLISHING CUPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PC03B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T19:58:38.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847236021351</udiDi>
    <basicUdiDi>08472360IINST012UK</basicUdiDi>
    <tradeName>BioHorizons</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioHorizons Implant Systems Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014002</manufacturerSrn>
    <authorisedRepresentativeName>ALTATEC GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006232</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010599</emdnCode>
    <emdnDescription>DENTAL INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODSICT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-03T19:48:58.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944835197679</udiDi>
    <basicUdiDi>B-06944835197679</basicUdiDi>
    <tradeName>06944835197679</tradeName>
    <deviceName>Dental Root-canal Instruments</deviceName>
    <manufacturerName>SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027059</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB2CB0415D</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T16:51:29.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944835197662</udiDi>
    <basicUdiDi>B-06944835197662</basicUdiDi>
    <tradeName>06944835197662</tradeName>
    <deviceName>Dental Root-canal Instruments</deviceName>
    <manufacturerName>SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027059</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB2CB04G4D</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T16:51:25.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944835197655</udiDi>
    <basicUdiDi>B-06944835197655</basicUdiDi>
    <tradeName>06944835197655</tradeName>
    <deviceName>Dental Root-canal Instruments</deviceName>
    <manufacturerName>SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027059</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB2CB04F4D</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T16:51:24.546Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944835197648</udiDi>
    <basicUdiDi>B-06944835197648</basicUdiDi>
    <tradeName>06944835197648</tradeName>
    <deviceName>Dental Root-canal Instruments</deviceName>
    <manufacturerName>SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027059</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB2CB04E4D</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T16:51:23.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944835197631</udiDi>
    <basicUdiDi>B-06944835197631</basicUdiDi>
    <tradeName>06944835197631</tradeName>
    <deviceName>Dental Root-canal Instruments</deviceName>
    <manufacturerName>SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027059</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB2CB04D4D</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T16:51:22.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944835197624</udiDi>
    <basicUdiDi>B-06944835197624</basicUdiDi>
    <tradeName>06944835197624</tradeName>
    <deviceName>Dental Root-canal Instruments</deviceName>
    <manufacturerName>SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027059</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB2CB04C4D</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T16:51:18.942Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944835197617</udiDi>
    <basicUdiDi>B-06944835197617</basicUdiDi>
    <tradeName>06944835197617</tradeName>
    <deviceName>Dental Root-canal Instruments</deviceName>
    <manufacturerName>SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027059</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB2CB04B4D</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T16:51:18.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944835197600</udiDi>
    <basicUdiDi>B-06944835197600</basicUdiDi>
    <tradeName>06944835197600</tradeName>
    <deviceName>Dental Root-canal Instruments</deviceName>
    <manufacturerName>SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027059</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB2CB0415A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T16:51:17.326Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944835197594</udiDi>
    <basicUdiDi>B-06944835197594</basicUdiDi>
    <tradeName>06944835197594</tradeName>
    <deviceName>Dental Root-canal Instruments</deviceName>
    <manufacturerName>SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027059</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB2CB04G4A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T16:51:16.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944835197587</udiDi>
    <basicUdiDi>B-06944835197587</basicUdiDi>
    <tradeName>06944835197587</tradeName>
    <deviceName>Dental Root-canal Instruments</deviceName>
    <manufacturerName>SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027059</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB2CB04F4A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T16:51:12.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944835197570</udiDi>
    <basicUdiDi>B-06944835197570</basicUdiDi>
    <tradeName>06944835197570</tradeName>
    <deviceName>Dental Root-canal Instruments</deviceName>
    <manufacturerName>SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027059</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB2CB04E4A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T16:51:11.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944835197563</udiDi>
    <basicUdiDi>B-06944835197563</basicUdiDi>
    <tradeName>06944835197563</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027059</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</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>AB2CB04A4A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T16:50:59.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944835197556</udiDi>
    <basicUdiDi>B-06944835197556</basicUdiDi>
    <tradeName>06944835197556</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027059</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</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>AB2CB04C4A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T16:50:58.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944835197549</udiDi>
    <basicUdiDi>B-06944835197549</basicUdiDi>
    <tradeName>06944835197549</tradeName>
    <deviceName>Dental Root-canal Instruments</deviceName>
    <manufacturerName>SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027059</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB2CB04B4A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T16:50:54.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944835197532</udiDi>
    <basicUdiDi>B-06944835197532</basicUdiDi>
    <tradeName>06944835197532</tradeName>
    <deviceName>Dental Root-canal Instruments</deviceName>
    <manufacturerName>SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027059</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB2CB0415A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T16:50:54.066Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944835197525</udiDi>
    <basicUdiDi>B-06944835197525</basicUdiDi>
    <tradeName>06944835197525</tradeName>
    <deviceName>Dental Root-canal Instruments</deviceName>
    <manufacturerName>SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027059</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB2CB04G4A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T16:50:53.263Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944835197518</udiDi>
    <basicUdiDi>B-06944835197518</basicUdiDi>
    <tradeName>06944835197518</tradeName>
    <deviceName>Dental Root-canal Instruments</deviceName>
    <manufacturerName>SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027059</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB2CB04F4A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T16:50:52.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944835197501</udiDi>
    <basicUdiDi>B-06944835197501</basicUdiDi>
    <tradeName>06944835197501</tradeName>
    <deviceName>Dental Root-canal Instruments</deviceName>
    <manufacturerName>SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027059</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB2CB04E4A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T16:50:48.463Z</lastUpdated>
  </row>
</eudamedExport>