<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05944784000014</udiDi>
    <basicUdiDi>5944784ORTMEMBRUINFSOLDM8</basicUdiDi>
    <tradeName>ProfiTEX Hip joint</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrtoProfil Prod Romania SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000000526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HIP ORTHOSES (INCLUDING ABDUCTION ORTHOSES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4X.CENTPROT</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:17.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944784000021</udiDi>
    <basicUdiDi>5944784ORTMEMBRUINFLSCCKE</basicUdiDi>
    <tradeName>ProfiTEX de abductie copii I</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrtoProfil Prod Romania SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000000526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HIP ORTHOSES (INCLUDING ABDUCTION ORTHOSES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4X.CHA028-I</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:17.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944784000038</udiDi>
    <basicUdiDi>5944784ORTMEMBRUINFLSCCKE</basicUdiDi>
    <tradeName>ProfiTEX Ham Pavlik I</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrtoProfil Prod Romania SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000000526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HIP ORTHOSES (INCLUDING ABDUCTION ORTHOSES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4X.PAVLIK-I</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:17.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944784000045</udiDi>
    <basicUdiDi>5944784ORTMEMBRUINFLSCCKE</basicUdiDi>
    <tradeName>ProfiTEX de abductie copii III</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrtoProfil Prod Romania SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000000526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HIP ORTHOSES (INCLUDING ABDUCTION ORTHOSES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4X.CHA028-III</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:17.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944784000052</udiDi>
    <basicUdiDi>5944784ORTMEMBRUINFLSCCKE</basicUdiDi>
    <tradeName>ProfiTEX Ham Pavlik II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrtoProfil Prod Romania SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000000526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HIP ORTHOSES (INCLUDING ABDUCTION ORTHOSES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4X.PAVLIK-II</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:17.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944784000069</udiDi>
    <basicUdiDi>5944784ORTMEMBRUINFLSCCKE</basicUdiDi>
    <tradeName>ProfiTEX de abductie copii V</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrtoProfil Prod Romania SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000000526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HIP ORTHOSES (INCLUDING ABDUCTION ORTHOSES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4X.CHA028-V</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:17.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944784000076</udiDi>
    <basicUdiDi>5944784ORTMEMBRUINFLSCCKE</basicUdiDi>
    <tradeName>ProfiTEX de abductie copii II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrtoProfil Prod Romania SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000000526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HIP ORTHOSES (INCLUDING ABDUCTION ORTHOSES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4X.CHA028-II</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:17.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944784000083</udiDi>
    <basicUdiDi>5944784ORTMEMBRUINFLSCCKE</basicUdiDi>
    <tradeName>ProfiTEX Ham Pavlik III</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrtoProfil Prod Romania SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000000526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HIP ORTHOSES (INCLUDING ABDUCTION ORTHOSES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4X.PAVLIK-III</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:17.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944784000090</udiDi>
    <basicUdiDi>5944784ORTMEMBRUINFLSCCKE</basicUdiDi>
    <tradeName>ProfiTEX de abductie copii IV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrtoProfil Prod Romania SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000000526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HIP ORTHOSES (INCLUDING ABDUCTION ORTHOSES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4X.CHA028-IV</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:17.822Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944784000106</udiDi>
    <basicUdiDi>5944784ORTMEMRUSUPOIMMKS</basicUdiDi>
    <tradeName>ProfiTEX Carpieră cu atelă III</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrtoProfil Prod Romania SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000000526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4X.O-151-III</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:17.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944784000113</udiDi>
    <basicUdiDi>5944784ORTMEMRUSUPOIMMKS</basicUdiDi>
    <tradeName>ProfiTEX Carpieră cu atelă V</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrtoProfil Prod Romania SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000000526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4X.O-151-V</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:17.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944784000120</udiDi>
    <basicUdiDi>5944784ORTMEMRUSUPOIMMKS</basicUdiDi>
    <tradeName>ProfiTEX Carpieră simplă I</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrtoProfil Prod Romania SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000000526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4X.S-543-I</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:17.775Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944784000137</udiDi>
    <basicUdiDi>5944784ORTMEMRUSUPOIMMKS</basicUdiDi>
    <tradeName>ProfiTEX Carpieră simplă II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrtoProfil Prod Romania SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000000526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4X.S-543-II</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:17.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944784000144</udiDi>
    <basicUdiDi>5944784ORTMEMRUSUPOIMMKS</basicUdiDi>
    <tradeName>ProfiTEX Carpieră simplă III</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrtoProfil Prod Romania SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000000526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4X.S-543-III</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:17.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944784000151</udiDi>
    <basicUdiDi>5944784ORTMEMRUSUPOIMMKS</basicUdiDi>
    <tradeName>ProfiTEX Carpieră cu atelă I</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrtoProfil Prod Romania SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000000526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4X.O-151-I</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:17.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944784000168</udiDi>
    <basicUdiDi>5944784ORTMEMRUSUPOIMMKS</basicUdiDi>
    <tradeName>ProfiTEX Carpieră cu atelă IV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrtoProfil Prod Romania SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000000526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4X.O-151-IV</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:17.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944784000175</udiDi>
    <basicUdiDi>5944784ORTMEMRUSUPOIMMKS</basicUdiDi>
    <tradeName>ProfiTEX Carpieră cu atelă II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrtoProfil Prod Romania SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000000526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4X.O-151-II</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:17.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944784000182</udiDi>
    <basicUdiDi>5944784ORTMEMRUSUPOIMMKS</basicUdiDi>
    <tradeName>ProfiTEX Carpieră simplă IV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrtoProfil Prod Romania SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000000526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4X.S-543-IV</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:17.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944784000199</udiDi>
    <basicUdiDi>5944784ORTMEMRUSUPOIMMKS</basicUdiDi>
    <tradeName>ProfiTEX Carpieră simplă V</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrtoProfil Prod Romania SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000000526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4X.S-543-V</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:17.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944784000205</udiDi>
    <basicUdiDi>5944784ORTMEMBRUINFOCSPKV</basicUdiDi>
    <tradeName>ProfiTEX PodoCare FLAT SHELL41</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrtoProfil Prod Romania SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000000526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4STO.FLAT SHELL-41</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:10:17.641Z</lastUpdated>
  </row>
</eudamedExport>