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<eudamedExport entity="devices">
  <row>
    <udiDi>05944760260234</udiDi>
    <basicUdiDi>594476026ELTLFM000001M4</basicUdiDi>
    <tradeName>Solid ankle foot</tradeName>
    <deviceName>Prosthetic feet</deviceName>
    <manufacturerName>Elitex Prodexim SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000033014</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y062403</emdnCode>
    <emdnDescription>FOOT PARTIAL PROSTHESES (INCLUDING TOE PROSTHESES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LF-10</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:27:42.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944760260203</udiDi>
    <basicUdiDi>594476026ELTS00000001WP</basicUdiDi>
    <tradeName>Free-moving orthotic knee joint</tradeName>
    <deviceName>Orthoses</deviceName>
    <manufacturerName>Elitex Prodexim SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000033014</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y06121201</emdnCode>
    <emdnDescription>PASSIVE KNEE-ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S5</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:27:41.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944760260005</udiDi>
    <basicUdiDi>594476026ELTABCG00001EF</basicUdiDi>
    <tradeName>Shuttle lock</tradeName>
    <deviceName>Modular pieces for prosthetic leg</deviceName>
    <manufacturerName>Elitex Prodexim SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000033014</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y062415</emdnCode>
    <emdnDescription>TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:27:40.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944760260012</udiDi>
    <basicUdiDi>594476026ELTABCG00001EF</basicUdiDi>
    <tradeName>Socket adapter with adjustment core</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elitex Prodexim SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000033014</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y062415</emdnCode>
    <emdnDescription>TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A31</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:18.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944760260029</udiDi>
    <basicUdiDi>594476026ELTABCG00001EF</basicUdiDi>
    <tradeName>Double adapter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elitex Prodexim SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000033014</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y062415</emdnCode>
    <emdnDescription>TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B30</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:18.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944760260036</udiDi>
    <basicUdiDi>594476026ELTABCG00001EF</basicUdiDi>
    <tradeName>Socket adapter with rotatable adjustment core support</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elitex Prodexim SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000033014</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y062415</emdnCode>
    <emdnDescription>TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A35</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:18.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944760260043</udiDi>
    <basicUdiDi>594476026ELTABCG00001EF</basicUdiDi>
    <tradeName>Single-axis foot adapter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elitex Prodexim SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000033014</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y062415</emdnCode>
    <emdnDescription>TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GLE10</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:18.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944760260050</udiDi>
    <basicUdiDi>594476026ELTABCG00001EF</basicUdiDi>
    <tradeName>Tube adapter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elitex Prodexim SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000033014</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y062415</emdnCode>
    <emdnDescription>TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B50</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:18.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944760260067</udiDi>
    <basicUdiDi>594476026ELTABCG00001EF</basicUdiDi>
    <tradeName>Slide adapter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elitex Prodexim SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000033014</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y062415</emdnCode>
    <emdnDescription>TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B12</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:18.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944760260074</udiDi>
    <basicUdiDi>594476026ELTABCG00001EF</basicUdiDi>
    <tradeName>Eccentric adapter with adjustment core support</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elitex Prodexim SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000033014</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y062415</emdnCode>
    <emdnDescription>TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A37</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:18.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944760260081</udiDi>
    <basicUdiDi>594476026ELTABCG00001EF</basicUdiDi>
    <tradeName>Foot adapter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elitex Prodexim SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000033014</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y062415</emdnCode>
    <emdnDescription>TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C10</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:18.549Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944760260098</udiDi>
    <basicUdiDi>594476026ELTABCG00001EF</basicUdiDi>
    <tradeName>Double adapter with adjustment core</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elitex Prodexim SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000033014</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y062415</emdnCode>
    <emdnDescription>TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B40</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:18.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944760260104</udiDi>
    <basicUdiDi>594476026ELTABCG00001EF</basicUdiDi>
    <tradeName>Tube clamp adapter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elitex Prodexim SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000033014</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y062415</emdnCode>
    <emdnDescription>TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B10</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:18.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944760260111</udiDi>
    <basicUdiDi>594476026ELTABCG00001EF</basicUdiDi>
    <tradeName>Lamination anchor with adjustment core for transfemoral socket</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elitex Prodexim SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000033014</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y062415</emdnCode>
    <emdnDescription>TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:18.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944760260128</udiDi>
    <basicUdiDi>594476026ELTABCG00001EF</basicUdiDi>
    <tradeName>Lamination anchor with rotatable adjustment core support</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elitex Prodexim SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000033014</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y062415</emdnCode>
    <emdnDescription>TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A20</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:18.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944760260135</udiDi>
    <basicUdiDi>594476026ELTABCG00001EF</basicUdiDi>
    <tradeName>Single-axis knee joint</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elitex Prodexim SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000033014</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y062415</emdnCode>
    <emdnDescription>TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GEN10</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:18.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944760260142</udiDi>
    <basicUdiDi>594476026ELTABCG00001EF</basicUdiDi>
    <tradeName>Single-axis knee joint</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elitex Prodexim SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000033014</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y062415</emdnCode>
    <emdnDescription>TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GEN40</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:18.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944760260159</udiDi>
    <basicUdiDi>594476026ELTABCG00001EF</basicUdiDi>
    <tradeName>Articulatie policentrica de genunchi</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elitex Prodexim SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000033014</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y062415</emdnCode>
    <emdnDescription>TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GEN30</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:18.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944760260166</udiDi>
    <basicUdiDi>594476026ELTABCG00001EF</basicUdiDi>
    <tradeName>Lamination anchor with adjustment core for transtibial socket</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elitex Prodexim SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000033014</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y062415</emdnCode>
    <emdnDescription>TRANSTIBIAL PROSTHESES (FOR AMPUTATION UNDER KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A10</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:18.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944760260173</udiDi>
    <basicUdiDi>594476026ELTABCG00001EF</basicUdiDi>
    <tradeName>Lamination anchor with rotatable adjustment core</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Elitex Prodexim SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000033014</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y062415</emdnCode>
    <emdnDescription>TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A21</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:18.423Z</lastUpdated>
  </row>
</eudamedExport>