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    <basicUdiDi>47198728663WQ</basicUdiDi>
    <tradeName>ROM Walking Boot</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhangpu Ortholife Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011447</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(XL/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T02:59:58.886Z</lastUpdated>
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    <udiDi>04719892931205</udiDi>
    <basicUdiDi>47198728663WQ</basicUdiDi>
    <tradeName>ROM Air Walking Boot</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhangpu Ortholife Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011447</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(17M/UNI/Black)</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-26T02:59:58.858Z</lastUpdated>
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  <row>
    <udiDi>04719892931212</udiDi>
    <basicUdiDi>47198728663WQ</basicUdiDi>
    <tradeName>ROM Air Walking Boot</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhangpu Ortholife Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011447</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(17L/UNI/Black)</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-26T02:59:58.834Z</lastUpdated>
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  <row>
    <udiDi>04719892931229</udiDi>
    <basicUdiDi>47198728663WQ</basicUdiDi>
    <tradeName>Power Walking Boot</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhangpu Ortholife Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011447</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(11S/UNI/Black)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T02:59:58.812Z</lastUpdated>
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  <row>
    <udiDi>04719892931236</udiDi>
    <basicUdiDi>47198728663WQ</basicUdiDi>
    <tradeName>Power Walking Boot</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhangpu Ortholife Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011447</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(11S/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T02:59:58.789Z</lastUpdated>
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  <row>
    <udiDi>04719892931243</udiDi>
    <basicUdiDi>47198728663WQ</basicUdiDi>
    <tradeName>Power Walking Boot</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhangpu Ortholife Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011447</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(17S/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T02:59:58.764Z</lastUpdated>
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  <row>
    <udiDi>04719892931250</udiDi>
    <basicUdiDi>47198728663WQ</basicUdiDi>
    <tradeName>Power Walking Boot</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhangpu Ortholife Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011447</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(11M/UNI/Black)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T02:59:58.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892931267</udiDi>
    <basicUdiDi>47198728663WQ</basicUdiDi>
    <tradeName>Power Walking Boot</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhangpu Ortholife Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011447</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(11M/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T02:59:58.725Z</lastUpdated>
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  <row>
    <udiDi>04719892931274</udiDi>
    <basicUdiDi>47198728663WQ</basicUdiDi>
    <tradeName>Power Walking Boot</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhangpu Ortholife Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011447</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(17M/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T02:59:58.713Z</lastUpdated>
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  <row>
    <udiDi>04719892931281</udiDi>
    <basicUdiDi>47198728663WQ</basicUdiDi>
    <tradeName>Power Walking Boot</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhangpu Ortholife Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011447</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(11L/UNI/Black)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T02:59:58.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892931298</udiDi>
    <basicUdiDi>47198728663WQ</basicUdiDi>
    <tradeName>Power Walking Boot</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhangpu Ortholife Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011447</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(11L/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T02:59:58.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892931304</udiDi>
    <basicUdiDi>47198728663WQ</basicUdiDi>
    <tradeName>Power Walking Boot</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhangpu Ortholife Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011447</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(17L/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T02:59:38.270Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892931311</udiDi>
    <basicUdiDi>47198728663WQ</basicUdiDi>
    <tradeName>Power Walking Boot</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhangpu Ortholife Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011447</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(11XL/UNI/Black)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T02:59:38.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892931328</udiDi>
    <basicUdiDi>47198728663WQ</basicUdiDi>
    <tradeName>Power Walking Boot</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhangpu Ortholife Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011447</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(11XL/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T02:59:38.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892931335</udiDi>
    <basicUdiDi>47198728663WQ</basicUdiDi>
    <tradeName>Power Walking Boot</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhangpu Ortholife Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011447</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(17XL/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T02:59:38.223Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892931342</udiDi>
    <basicUdiDi>47198728663WQ</basicUdiDi>
    <tradeName>GoFit Walker</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhangpu Ortholife Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011447</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>635302(11XS/UNI/Black)</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-26T02:59:38.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892931359</udiDi>
    <basicUdiDi>47198728663WQ</basicUdiDi>
    <tradeName>GoFit Walker</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhangpu Ortholife Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011447</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>635302(17XS/UNI/Black)</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-26T02:59:38.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892931366</udiDi>
    <basicUdiDi>47198728663WQ</basicUdiDi>
    <tradeName>GoFit Walker</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhangpu Ortholife Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011447</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>635302(11S/UNI/Black)</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-26T02:59:38.169Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892931373</udiDi>
    <basicUdiDi>47198728663WQ</basicUdiDi>
    <tradeName>GoFit Walker</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhangpu Ortholife Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011447</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>635302(11S/UNI/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-26T02:59:38.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719892931380</udiDi>
    <basicUdiDi>47198728641WE</basicUdiDi>
    <tradeName>Wrist Brace</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhangpu Ortholife Rehabilitation Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011447</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>410005(XL/Right/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T02:59:38.100Z</lastUpdated>
  </row>
</eudamedExport>