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    <udiDi>04946452068112</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>FILMISTA ANKLE (ankle support) Right XL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nippon Sigmax Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000016727</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>670204</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068129</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>FILMISTA ANKLE (ankle support) Left S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nippon Sigmax Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000016727</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>670211</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068136</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>FILMISTA ANKLE (ankle support) Left M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nippon Sigmax Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000016727</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>670212</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068143</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>FILMISTA ANKLE (ankle support) Left L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nippon Sigmax Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000016727</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>670213</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068150</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>FILMISTA ANKLE (ankle support) Left XL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nippon Sigmax Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000016727</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>670214</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.076Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068167</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>JK Band (knee support) XS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nippon Sigmax Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000016727</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>671000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068174</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>JK Band (knee support) S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nippon Sigmax Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000016727</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>671001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068181</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>JK Band (knee support) M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nippon Sigmax Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000016727</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>671002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068198</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>JK Band (knee support) L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nippon Sigmax Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000016727</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>671003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068204</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>JK Band (knee support) XL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nippon Sigmax Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000016727</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>671004</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.976Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068211</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>JK-2 (knee support) S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nippon Sigmax Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000016727</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>671201</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.957Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068228</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>JK-2 (knee support) M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nippon Sigmax Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000016727</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>671202</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068235</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>JK-2 (knee support) L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nippon Sigmax Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000016727</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>671203</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068242</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>JK-2 (knee support) XL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nippon Sigmax Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000016727</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>671204</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.885Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068259</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>JK-2 (knee support) 2XL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nippon Sigmax Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000016727</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>671205</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068266</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>EK-1 (knee support) S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nippon Sigmax Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000016727</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>671801</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.836Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068273</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>EK-1 (knee support) M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nippon Sigmax Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000016727</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>671802</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068280</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>EK-1 (knee support) L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nippon Sigmax Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000016727</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>671803</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068297</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>EK-1 (knee support) XL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nippon Sigmax Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000016727</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>671804</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068303</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>EK-3 (knee support) S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Nippon Sigmax Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000016727</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>671901</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.749Z</lastUpdated>
  </row>
</eudamedExport>