<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04719964461319</udiDi>
    <basicUdiDi>47199644664WQ</basicUdiDi>
    <tradeName>Heel Cup Central Spur</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>640004(L/UNI/White)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:36.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964461326</udiDi>
    <basicUdiDi>47199644664WQ</basicUdiDi>
    <tradeName>Heel Cup Central Spur</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>640004(M/UNI/White)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:36.191Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964461333</udiDi>
    <basicUdiDi>47199644664WQ</basicUdiDi>
    <tradeName>Heel Cup Central Spur</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>640004(S/UNI/White)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:36.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964461340</udiDi>
    <basicUdiDi>47199644664WQ</basicUdiDi>
    <tradeName>Heel Cup Central Spur</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>640004(XL/UNI/White)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:36.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964461395</udiDi>
    <basicUdiDi>47199644664WQ</basicUdiDi>
    <tradeName>Heel Cushion With Removable 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>ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>640006(L/UNI/White)</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:36.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964461401</udiDi>
    <basicUdiDi>47199644664WQ</basicUdiDi>
    <tradeName>Heel Cushion With Removable 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>ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>640006(M/UNI/White)</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:36.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964461418</udiDi>
    <basicUdiDi>47199644664WQ</basicUdiDi>
    <tradeName>Heel Cushion With Removable 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>ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>640006(S/UNI/White)</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:36.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964461470</udiDi>
    <basicUdiDi>47199644665WS</basicUdiDi>
    <tradeName>Bunion 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>ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>650001(L/Right/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:36.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964461487</udiDi>
    <basicUdiDi>47199644665WS</basicUdiDi>
    <tradeName>Bunion 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>ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>650001(M/Left/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:36.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964461494</udiDi>
    <basicUdiDi>47199644665WS</basicUdiDi>
    <tradeName>Bunion 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>ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>650001(M/Right/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:36.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964461500</udiDi>
    <basicUdiDi>47199644665WS</basicUdiDi>
    <tradeName>Bunion 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>ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>650001(S/Left/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:17.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964461517</udiDi>
    <basicUdiDi>47199644665WS</basicUdiDi>
    <tradeName>Bunion 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>ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>650001(S/Right/Gray&amp;Silver)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:17.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964461524</udiDi>
    <basicUdiDi>47199644665WS</basicUdiDi>
    <tradeName>Bunion Night 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>650002(L/Left/White)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:17.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964461531</udiDi>
    <basicUdiDi>47199644665WS</basicUdiDi>
    <tradeName>Bunion Night 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>650002(L/Right/White)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:17.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964461548</udiDi>
    <basicUdiDi>47199644665WS</basicUdiDi>
    <tradeName>Bunion Night 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>650002(M/Left/White)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:17.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964461555</udiDi>
    <basicUdiDi>47199644665WS</basicUdiDi>
    <tradeName>Bunion Night 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>650002(M/Right/White)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:17.313Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964461562</udiDi>
    <basicUdiDi>47199644665WS</basicUdiDi>
    <tradeName>Bunion Night 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>650002(S/Left/White)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:17.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964461579</udiDi>
    <basicUdiDi>47199644665WS</basicUdiDi>
    <tradeName>Bunion Night 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>650002(S/Right/White)</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:17.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964461586</udiDi>
    <basicUdiDi>47199644665WS</basicUdiDi>
    <tradeName>Tubular Toe Protector</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>650003(L/UNI/Beige)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:17.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719964461593</udiDi>
    <basicUdiDi>47199644665WS</basicUdiDi>
    <tradeName>Tubular Toe Protector</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>650003(M/UNI/Beige)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:56:17.246Z</lastUpdated>
  </row>
</eudamedExport>