<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04946452068310</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>EK-3 (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>671902</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068327</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>EK-3 (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>671903</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068334</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>EK-3 (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>671904</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068419</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>ZK-X (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>681001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068426</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>ZK-X (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>681002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068433</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>ZK-X (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>681003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068440</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>ZK-X (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>681004</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068457</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>ZK-X (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>681005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068464</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>ZK-X (knee support) 3XL</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>681006</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068471</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>ZK-X (knee support) 4XL</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>681007</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068488</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>Thumb Guard 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-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>674301</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068495</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>Thumb Guard 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-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>674302</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.498Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068501</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>Thumb Guard 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>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>674303</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068518</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>Ice Bag 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>CRYOTHERAPY AND THERMOTHERAPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>678101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068525</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>Ice Bag 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></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>678102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068532</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>Ice Bag 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>CRYOTHERAPY AND THERMOTHERAPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>678103</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068549</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>ZW-5 (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>683500</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.410Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068556</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>ZW-5 (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>683501</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068563</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>ZW-5 (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>683502</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>04946452068570</udiDi>
    <basicUdiDi>4946452SIG001VS</basicUdiDi>
    <tradeName>ZW-5 (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>683503</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:17:11.378Z</lastUpdated>
  </row>
</eudamedExport>