<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>15025392350733</udiDi>
    <basicUdiDi>50253920000000000000007WE</basicUdiDi>
    <tradeName>VULKAN TENNIS ELBOW BRACE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Performance Health International LTD</manufacturerName>
    <manufacturerSrn>GB-MF-000003319</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061812</emdnCode>
    <emdnDescription>ELBOW DISARTICULATION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>081572544</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-28T03:57:47.168Z</lastUpdated>
  </row>
  <row>
    <udiDi>15025392350719</udiDi>
    <basicUdiDi>50253920000000000000007WE</basicUdiDi>
    <tradeName>VULKAN TENNIS ELBOW BRACE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Performance Health International LTD</manufacturerName>
    <manufacturerSrn>GB-MF-000003319</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061812</emdnCode>
    <emdnDescription>ELBOW DISARTICULATION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>081572528</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-28T03:57:37.516Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057971595785</udiDi>
    <basicUdiDi>805797159AHY5</basicUdiDi>
    <tradeName>Pulse Hub</tradeName>
    <deviceName>Adam's Hand</deviceName>
    <manufacturerName>BionIT Labs S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000007793</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061899</emdnCode>
    <emdnDescription>UPPER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VFH01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-24T20:11:16.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>15025392350702</udiDi>
    <basicUdiDi>50253920000000000000007WE</basicUdiDi>
    <tradeName>VULKAN TENNIS ELBOW BRACE</tradeName>
    <deviceName>UPPER EXTREMITY</deviceName>
    <manufacturerName>Performance Health International LTD</manufacturerName>
    <manufacturerSrn>GB-MF-000003319</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061812</emdnCode>
    <emdnDescription>ELBOW DISARTICULATION PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>081572510</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:57:34.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057971595792</udiDi>
    <basicUdiDi>805797159AHY5</basicUdiDi>
    <tradeName>Adam's Hand Plus</tradeName>
    <deviceName>Adam's Hand</deviceName>
    <manufacturerName>BionIT Labs S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000007793</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061899</emdnCode>
    <emdnDescription>UPPER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH03-LS1-W1-01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:13:41.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>05061081787780</udiDi>
    <basicUdiDi>506108178ALXBE4X</basicUdiDi>
    <tradeName>ALX EDGA Golf SB</tradeName>
    <deviceName>ALX BELOW ELBOW PROSTHESIS</deviceName>
    <manufacturerName>Koalaa Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000045260</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061809</emdnCode>
    <emdnDescription>TRANSRADIAL PROSTHESES (FOR AMPUTATION UNDER ELBOW)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KA30</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:07:16.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057971595815</udiDi>
    <basicUdiDi>805797159AHY5</basicUdiDi>
    <tradeName>Adam's Hand Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BionIT Labs S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000007793</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061899</emdnCode>
    <emdnDescription>UPPER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH03-LS1-B1-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:52:50.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057971595822</udiDi>
    <basicUdiDi>805797159AHY5</basicUdiDi>
    <tradeName>Adam's Hand Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BionIT Labs S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000007793</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061899</emdnCode>
    <emdnDescription>UPPER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH03-RS1-B1-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:52:48.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057971595808</udiDi>
    <basicUdiDi>805797159AHY5</basicUdiDi>
    <tradeName>Adam's Hand Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BionIT Labs S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000007793</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061899</emdnCode>
    <emdnDescription>UPPER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH03-RS1-W1-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:52:46.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057971595839</udiDi>
    <basicUdiDi>805797159AHY5</basicUdiDi>
    <tradeName>Adam's Hand Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BionIT Labs S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000007793</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061899</emdnCode>
    <emdnDescription>UPPER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH03-LS1-N1-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:52:46.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057971595846</udiDi>
    <basicUdiDi>805797159AHY5</basicUdiDi>
    <tradeName>Adam's Hand Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BionIT Labs S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000007793</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061899</emdnCode>
    <emdnDescription>UPPER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH03-RS1-N1-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:52:45.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057971595853</udiDi>
    <basicUdiDi>805797159AHY5</basicUdiDi>
    <tradeName>Adam's Hand Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BionIT Labs S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000007793</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061899</emdnCode>
    <emdnDescription>UPPER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH03-LS1-N2-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:52:45.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057971595860</udiDi>
    <basicUdiDi>805797159AHY5</basicUdiDi>
    <tradeName>Adam's Hand Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BionIT Labs S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000007793</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061899</emdnCode>
    <emdnDescription>UPPER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH03-RS1-N2-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:52:44.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057971595877</udiDi>
    <basicUdiDi>805797159AHY5</basicUdiDi>
    <tradeName>Adam's Hand Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BionIT Labs S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000007793</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061899</emdnCode>
    <emdnDescription>UPPER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH03-LS1-N3-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:52:44.044Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057971595884</udiDi>
    <basicUdiDi>805797159AHY5</basicUdiDi>
    <tradeName>Adam's Hand Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BionIT Labs S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000007793</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061899</emdnCode>
    <emdnDescription>UPPER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH03-RS1-N3-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:52:40.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057971595891</udiDi>
    <basicUdiDi>805797159AHY5</basicUdiDi>
    <tradeName>Adam's Hand Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BionIT Labs S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000007793</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061899</emdnCode>
    <emdnDescription>UPPER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH03-LS1-N4-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:52:39.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057971595907</udiDi>
    <basicUdiDi>805797159AHY5</basicUdiDi>
    <tradeName>Adam's Hand Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BionIT Labs S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000007793</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061899</emdnCode>
    <emdnDescription>UPPER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH03-RS1-N4-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:52:39.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057971595914</udiDi>
    <basicUdiDi>805797159AHY5</basicUdiDi>
    <tradeName>Adam's Hand Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BionIT Labs S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000007793</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061899</emdnCode>
    <emdnDescription>UPPER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH03-LS1-N5-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:52:34.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057971595921</udiDi>
    <basicUdiDi>805797159AHY5</basicUdiDi>
    <tradeName>Adam's Hand Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BionIT Labs S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000007793</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061899</emdnCode>
    <emdnDescription>UPPER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH03-RS1-N5-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:52:34.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057971595938</udiDi>
    <basicUdiDi>805797159AHY5</basicUdiDi>
    <tradeName>Adam's Hand Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BionIT Labs S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000007793</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061899</emdnCode>
    <emdnDescription>UPPER EXTREMITY PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH03-LS1-N6-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:52:33.352Z</lastUpdated>
  </row>
</eudamedExport>