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    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>Filmista Wrist 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>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>674002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.625Z</lastUpdated>
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    <udiDi>04946452067924</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>A2-DX (ankle support) Black Right 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>670601</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.604Z</lastUpdated>
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    <udiDi>04946452067931</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>A2-DX (ankle support) Black Right 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>670602</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.584Z</lastUpdated>
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    <udiDi>04946452067948</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>A2-DX (ankle support) Black Right 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>670603</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.564Z</lastUpdated>
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    <udiDi>04946452067955</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>A2-DX (ankle support) Black 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>670604</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452067962</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>A2-DX (ankle support) Black 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>670611</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.515Z</lastUpdated>
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  <row>
    <udiDi>04946452067979</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>A2-DX (ankle support) Black 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>670612</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452067986</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>A2-DX (ankle support) Black 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>670613</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.474Z</lastUpdated>
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  <row>
    <udiDi>04946452067993</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>A2-DX (ankle support) Black 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>670614</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.451Z</lastUpdated>
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  <row>
    <udiDi>04946452068006</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>A2-DX (ankle support) White Right 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>670641</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.428Z</lastUpdated>
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  <row>
    <udiDi>04946452068013</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>A2-DX (ankle support) White Right 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>670642</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068020</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>A2-DX (ankle support) White Right 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>670643</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068037</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>A2-DX (ankle support) White 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>670644</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068044</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>A2-DX (ankle support) White 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>670651</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068051</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>A2-DX (ankle support) White 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>670652</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068068</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>A2-DX (ankle support) White 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>670653</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068075</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>A2-DX (ankle support) White 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>670654</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068082</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>FILMISTA ANKLE (ankle support) Right 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>670201</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068099</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>FILMISTA ANKLE (ankle support) Right 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>670202</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068105</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>FILMISTA ANKLE (ankle support) Right 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>670203</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.199Z</lastUpdated>
  </row>
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