<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>Y060612</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>Y060612</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>Y060612</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>Y060612</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>Y060612</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>Y060612</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>Y060612</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>Y060612</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>08906204020634</udiDi>
    <basicUdiDi>890620402WHSN4</basicUdiDi>
    <tradeName>Wrist &amp; Forearm Splint</tradeName>
    <deviceName>Wrist Thumb Splint Support</deviceName>
    <manufacturerName>Malu Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000050447</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060612</emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-02</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:54:30.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906204020627</udiDi>
    <basicUdiDi>890620402WBW3</basicUdiDi>
    <tradeName>Wrist Brace</tradeName>
    <deviceName>Wrist Brace</deviceName>
    <manufacturerName>Malu Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000050447</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060612</emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:54:30.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906176123203</udiDi>
    <basicUdiDi>890617612M400R86</basicUdiDi>
    <tradeName>08906176123203</tradeName>
    <deviceName>Elastic Wrist Splint</deviceName>
    <manufacturerName>Medequip Healthcare Solutions Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000039598</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060612</emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Elastic Wrist Splint (Right Hand)</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:49:42.749Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906176123197</udiDi>
    <basicUdiDi>890617612M400L7S</basicUdiDi>
    <tradeName>08906176123197</tradeName>
    <deviceName>Elastic Wrist Splint</deviceName>
    <manufacturerName>Medequip Healthcare Solutions Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000039598</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060612</emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Elastic Wrist Splint (Left Hand)</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:49:41.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906176122626</udiDi>
    <basicUdiDi>890617612M406DG</basicUdiDi>
    <tradeName>08906176122626</tradeName>
    <deviceName>Wrist Support with Thumb</deviceName>
    <manufacturerName>Medequip Healthcare Solutions Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000039598</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060612</emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Wrist Support with Thumb (Universal)</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:49:16.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906176122619</udiDi>
    <basicUdiDi>890617612MN07HF</basicUdiDi>
    <tradeName>08906176122619</tradeName>
    <deviceName>Wrist Support Neoprene</deviceName>
    <manufacturerName>Medequip Healthcare Solutions Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000039598</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060612</emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Wrist Support Neoprene (Universal)</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:49:12.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906176122602</udiDi>
    <basicUdiDi>890617612M405DE</basicUdiDi>
    <tradeName>08906176122602</tradeName>
    <deviceName>Wrist Support Double Lock</deviceName>
    <manufacturerName>Medequip Healthcare Solutions Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000039598</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060612</emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Wrist Support Double Lock (Universal)</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:49:11.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906176122497</udiDi>
    <basicUdiDi>890617612M10LM</basicUdiDi>
    <tradeName>08906176122497</tradeName>
    <deviceName>Weight Cuff</deviceName>
    <manufacturerName>Medequip Healthcare Solutions Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000039598</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060612</emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Weight Cuff 500 Gm</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:49:10.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>08719327702253</udiDi>
    <basicUdiDi>8720865045PSB-STAB78</basicUdiDi>
    <tradeName>Medilon Braces</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medilon Braces</manufacturerName>
    <manufacturerSrn>NL-MF-000047759</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060612</emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MB5223</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:02:48.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720256363019</udiDi>
    <basicUdiDi>8720256363OAPHSILR6</basicUdiDi>
    <tradeName>Siliconen Pols-Hand Orthese Met Duim</tradeName>
    <deviceName>Siliconen Pols-Hand Orthese</deviceName>
    <manufacturerName>Livit Orthopedie B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000548</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060612</emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OA-PH-SIL</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:46:17.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>08715669002969</udiDi>
    <basicUdiDi>87156691101W6</basicUdiDi>
    <tradeName>PUSH</tradeName>
    <deviceName>Push care Wrist Brace</deviceName>
    <manufacturerName>Nea International</manufacturerName>
    <manufacturerSrn>NL-MF-000006631</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060612</emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1.10.1.11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:18:29.522Z</lastUpdated>
  </row>
  <row>
    <udiDi>08591285104771</udiDi>
    <basicUdiDi>869755062Y06061204RF</basicUdiDi>
    <tradeName>Wrist support S premium</tradeName>
    <deviceName>WRIST-HAND ORTHOSES</deviceName>
    <manufacturerName>Arden Medical</manufacturerName>
    <manufacturerSrn>TR-MF-000026387</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060612</emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>4911-01-S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:42:41.532Z</lastUpdated>
  </row>
</eudamedExport>