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<eudamedExport entity="devices">
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    <basicUdiDi>47199644652WH</basicUdiDi>
    <tradeName>W-FLITE Knee Brace</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>527004(M/Right/Blue)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:52.002Z</lastUpdated>
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  <row>
    <udiDi>04719964467182</udiDi>
    <basicUdiDi>47199644652WH</basicUdiDi>
    <tradeName>W-FLITE Knee Brace</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>527004(XL/Left/Blue)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:51.981Z</lastUpdated>
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  <row>
    <udiDi>04719964467199</udiDi>
    <basicUdiDi>47199644652WH</basicUdiDi>
    <tradeName>W-FLITE Knee Brace</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>527004(XL/Right/Blue)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:51.966Z</lastUpdated>
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  <row>
    <udiDi>04719964467205</udiDi>
    <basicUdiDi>47199644624WC</basicUdiDi>
    <tradeName>VerteGuard</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THORACOLUMBAR ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>240007(Universal/UNI/Black)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:51.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964467212</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>Functional Position Splint</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND-FINGERS ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>417001(S/Right/Black)</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:51.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964467229</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>Functional Position Splint</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND-FINGERS ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>417001(S/Left/Black)</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:51.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964467236</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>Functional Position Splint</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND-FINGERS ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>417001(XL/Right/Black)</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:51.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964467243</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>Functional Position Splint</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND-FINGERS ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>417001(XL/Left/Black)</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:51.890Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964467298</udiDi>
    <basicUdiDi>47199644663WN</basicUdiDi>
    <tradeName>ROM Air Walking Boot Pro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>635204(M/UNI/Black)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:51.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964467304</udiDi>
    <basicUdiDi>47199644663WN</basicUdiDi>
    <tradeName>ROM Air Walking Boot Pro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>635204(L/UNI/Black)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:51.857Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964467311</udiDi>
    <basicUdiDi>47199644663WN</basicUdiDi>
    <tradeName>ROM Air Walking Boot Pro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>635204(14XL/UNI/Black)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:51.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964467342</udiDi>
    <basicUdiDi>47199644652WH</basicUdiDi>
    <tradeName>PCL Revive</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>527005(S/Left/Black)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:51.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964467359</udiDi>
    <basicUdiDi>47199644652WH</basicUdiDi>
    <tradeName>PCL Revive</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>527005(S/Right/Black)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:51.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964467366</udiDi>
    <basicUdiDi>47199644652WH</basicUdiDi>
    <tradeName>PCL Revive</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>527005(M/Left/Black)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:51.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964467373</udiDi>
    <basicUdiDi>47199644652WH</basicUdiDi>
    <tradeName>PCL Revive</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>527005(M/Right/Black)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:51.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964467380</udiDi>
    <basicUdiDi>47199644652WH</basicUdiDi>
    <tradeName>PCL Revive</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>527005(L/Left/Black)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:51.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964467397</udiDi>
    <basicUdiDi>47199644652WH</basicUdiDi>
    <tradeName>PCL Revive</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>527005(L/Right/Black)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:51.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964467403</udiDi>
    <basicUdiDi>47199644652WH</basicUdiDi>
    <tradeName>PCL Revive</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>527005(XL/Left/Black)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:51.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964467410</udiDi>
    <basicUdiDi>47199644652WH</basicUdiDi>
    <tradeName>PCL Revive</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>527005(XL/Right/Black)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:51.626Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964467427</udiDi>
    <basicUdiDi>47199644621W6</basicUdiDi>
    <tradeName>Shoulder Support</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orthotech Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051924</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SHOULDER ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>210004(2XL/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:51.606Z</lastUpdated>
  </row>
</eudamedExport>