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<eudamedExport entity="devices">
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    <udiDi>04946452068662</udiDi>
    <basicUdiDi>4946452SIG002VU</basicUdiDi>
    <tradeName>IW-1 Set (Icing wrap + Ice Bag)</tradeName>
    <deviceName>IW-1 SET</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CRYOTHERAPY AND THERMOTHERAPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>678301</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:58:48.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452066156</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>Shoulder Wrap M</tradeName>
    <deviceName>ZAMST</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SHOULDER ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>674802</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:58:48.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>04582506231707</udiDi>
    <basicUdiDi>4946452SIGI01ZJ</basicUdiDi>
    <tradeName>MUSCLE SUIT Soft-Light 2 M</tradeName>
    <deviceName>MEDIAID Assist Gear</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>MDR 2017/745</legislation>
    <emdnCode>Y060306</emdnCode>
    <emdnDescription>THORACOLUMBAR ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>307822</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:56:34.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452066163</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>Shoulder Wrap 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>SHOULDER ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>674803</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.974Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452066170</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>Shoulder Wrap 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>SHOULDER ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>674804</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452066217</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>FILMISTA KNEE (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>672201</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452066224</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>FILMISTA KNEE (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>672202</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452066231</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>FILMISTA KNEE (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>672203</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452067085</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>Elbow Band 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>ELBOW ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>674701</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452067092</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>Elbow Band 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>ELBOW ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>674702</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452067108</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>Elbow Band 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>ELBOW ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>674703</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452067443</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>A1 (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>670801</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452067450</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>A1 (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>670802</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452067467</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>A1 (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></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>670803</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452067474</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>A1 (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>670804</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452067481</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>A1 (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>670811</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452067498</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>A1 (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>670812</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452067504</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>A1 (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>670813</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452067511</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>A1 (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>670814</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452067528</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>Filmista Wrist 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>WRIST (FOREARM) ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>674001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:12.645Z</lastUpdated>
  </row>
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