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    <udiDi>04946452068587</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>ZW-5 (waist 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>THORACOLUMBAR ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>683504</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068594</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>ZW-5 (waist 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>THORACOLUMBAR ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>683505</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068600</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>ZW-7 (waist 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>THORACOLUMBAR ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>683700</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068617</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>ZW-7 (waist 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>THORACOLUMBAR ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>683701</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.335Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068624</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>ZW-7 (waist 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>THORACOLUMBAR ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>683702</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068631</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>ZW-7 (waist 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>THORACOLUMBAR ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>683703</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068648</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>ZW-7 (waist 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>THORACOLUMBAR ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>683704</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068655</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>ZW-7 (waist 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>THORACOLUMBAR ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>683705</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068679</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>JK-1 (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>671100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068686</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>JK-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>671101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068693</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>JK-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>671102</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068709</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>JK-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>671103</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068716</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>EK-5 (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>672001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068723</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>EK-5 (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>672002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068730</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>EK-5 (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>672003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068747</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>EK-5 (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>672004</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.148Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068884</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>RK-1 Plus (knee support) Right 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>682800</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068891</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>RK-1 Plus (knee 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>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>682801</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068907</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>RK-1 Plus (knee 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>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>682802</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068914</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>RK-1 Plus (knee 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>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>682803</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.104Z</lastUpdated>
  </row>
</eudamedExport>