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<eudamedExport entity="devices">
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    <udiDi>04719964468189</udiDi>
    <basicUdiDi>47199644631W9</basicUdiDi>
    <tradeName>Elbow Strap With Pad</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>ELBOW ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>310002(XL/UNI/Black)</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:50.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964468448</udiDi>
    <basicUdiDi>47199644663WN</basicUdiDi>
    <tradeName>Super Walking Boot</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>635104(11XS/UNI/Black)</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:50.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964468455</udiDi>
    <basicUdiDi>47199644663WN</basicUdiDi>
    <tradeName>Super Walking Boot</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>635104(17XS/UNI/Black)</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:50.348Z</lastUpdated>
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  <row>
    <udiDi>04719964468462</udiDi>
    <basicUdiDi>47199644663WN</basicUdiDi>
    <tradeName>Air Walking Boot</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>635102(11XS/UNI/Black)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:50.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964468479</udiDi>
    <basicUdiDi>47199644663WN</basicUdiDi>
    <tradeName>Air Walking Boot</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>635102(17XS/UNI/Black)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:50.327Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964468486</udiDi>
    <basicUdiDi>47199644663WN</basicUdiDi>
    <tradeName>ROM Walking Boot</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>635201(14XS/UNI/Black)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:50.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964468493</udiDi>
    <basicUdiDi>47199644663WN</basicUdiDi>
    <tradeName>ROM Walking Boot</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>635201(17XS/UNI/Black)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:50.301Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964468509</udiDi>
    <basicUdiDi>47199644663WN</basicUdiDi>
    <tradeName>ROM Air Walking Boot</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>635202(14XS/UNI/Black)</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:50.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964468516</udiDi>
    <basicUdiDi>47199644663WN</basicUdiDi>
    <tradeName>ROM Air Walking Boot</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>635202(17XS/UNI/Black)</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:50.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964468523</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(17XS/UNI/Black)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:50.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964468530</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(14XS/UNI/Black)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:50.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964468547</udiDi>
    <basicUdiDi>47199644663WN</basicUdiDi>
    <tradeName>Power Walking Boot</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>635301(11XS/UNI/Black)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:50.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964468554</udiDi>
    <basicUdiDi>47199644663WN</basicUdiDi>
    <tradeName>Power Walking Boot</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>635301(17XS/UNI/Black)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:50.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964469148</udiDi>
    <basicUdiDi>47199644665WS</basicUdiDi>
    <tradeName>Hinged Bunion 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>ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>650013(Universal/UNI/White)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:50.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964469155</udiDi>
    <basicUdiDi>47199644622W8</basicUdiDi>
    <tradeName>Posture Corrector</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>220005(Universal/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:50.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964469216</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></emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410009(XS/UNI/Black)</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:49.998Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964469223</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></emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410009(S/UNI/Black)</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:49.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964469230</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></emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410009(M/UNI/Black)</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:49.957Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964469247</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></emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410009(L/UNI/Black)</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:49.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964469254</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></emdnCode>
    <emdnDescription>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410009(XL/UNI/Black)</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:55:49.924Z</lastUpdated>
  </row>
</eudamedExport>