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<eudamedExport entity="devices">
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    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>Universal Wrist 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>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410008(L/XL/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:07:29.202Z</lastUpdated>
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  <row>
    <udiDi>04719892937979</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>Universal Wrist 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>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410008(S/M/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:07:29.187Z</lastUpdated>
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  <row>
    <udiDi>04719892937986</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>CTS Wrist Orthosis</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>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410009(L/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:07:29.170Z</lastUpdated>
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  <row>
    <udiDi>04719892937993</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>CTS Wrist Orthosis</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>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410009(M/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:07:29.156Z</lastUpdated>
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  <row>
    <udiDi>04719892938006</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>CTS Wrist Orthosis</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>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410009(S/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:07:29.143Z</lastUpdated>
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  <row>
    <udiDi>04719892938013</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>CTS Wrist Orthosis</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>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410009(XS/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:07:29.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892938020</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>WellKnit Wrist 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>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>414001(L/UNI/Black)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:07:29.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964461982</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>WellBind Thumb 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>Y060609</emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>413002(S/M/UNI/Black)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:16.709Z</lastUpdated>
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  <row>
    <udiDi>04719964461999</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>WellBind Thumb 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>Y060609</emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>413002(L/XL/UNI/Black)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:16.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964462002</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>WellBind Wrist 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>Y060609</emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>413001(S/UNI/Black)</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:16.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964462019</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>WellBind Wrist 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>Y060609</emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>413001(M/UNI/Black)</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:16.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964462026</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>WellBind Wrist 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>Y060609</emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>413001(L/UNI/Black)</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:16.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964462033</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>WellBind Wrist 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>Y060609</emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>413001(XL/UNI/Black)</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:16.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964463047</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>Y060609</emdnCode>
    <emdnDescription>WRIST-HAND-FINGERS ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>417001(XL/Left/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:16.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964463054</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>Y060609</emdnCode>
    <emdnDescription>WRIST-HAND-FINGERS ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>417001(XL/Right/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:16.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964463115</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>Thumb 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>Y060609</emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>412102(XS/Left/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:16.421Z</lastUpdated>
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  <row>
    <udiDi>04719964463122</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>Thumb 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>Y060609</emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>412102(XS/Right/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:16.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964463856</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>WellFit Wrist 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>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410010(S/Left/Black)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:15.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964463863</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>WellFit Wrist 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>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410010(S/Right/Black)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:15.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964463870</udiDi>
    <basicUdiDi>47199644641WC</basicUdiDi>
    <tradeName>WellFit Wrist 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>Y060609</emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410010(M/Left/Black)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:15.230Z</lastUpdated>
  </row>
</eudamedExport>