<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06980058103325</udiDi>
    <basicUdiDi>698005810UEOBKF</basicUdiDi>
    <tradeName>06980058103325</tradeName>
    <deviceName>Upper Extremity Orthosis Brace</deviceName>
    <manufacturerName>FORTUNE COMPANY LIMITED</manufacturerName>
    <manufacturerSrn>CN-MF-000023028</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060699</emdnCode>
    <emdnDescription>ORTHOSES, UPPER EXTREMITY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E02-UN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:29:26.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>06980058102298</udiDi>
    <basicUdiDi>698005810SOBQP</basicUdiDi>
    <tradeName>06980058102298</tradeName>
    <deviceName>Spinal Orthosis Brace</deviceName>
    <manufacturerName>FORTUNE COMPANY LIMITED</manufacturerName>
    <manufacturerSrn>CN-MF-000023028</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060399</emdnCode>
    <emdnDescription>SPINE ORTHOSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N01a-2.0</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:29:22.009Z</lastUpdated>
  </row>
  <row>
    <udiDi>06980058100720</udiDi>
    <basicUdiDi>698005810AHFOBC3</basicUdiDi>
    <tradeName>06980058100720</tradeName>
    <deviceName>Ankle, Heel &amp; Foot Orthosis Brace</deviceName>
    <manufacturerName>FORTUNE COMPANY LIMITED</manufacturerName>
    <manufacturerSrn>CN-MF-000023028</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061203</emdnCode>
    <emdnDescription>ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A01-S2</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:29:21.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>06980058100010</udiDi>
    <basicUdiDi>698005810KOBPF</basicUdiDi>
    <tradeName>06980058100010</tradeName>
    <deviceName>Knee Orthosis Brace</deviceName>
    <manufacturerName>FORTUNE COMPANY LIMITED</manufacturerName>
    <manufacturerSrn>CN-MF-000023028</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y061209</emdnCode>
    <emdnDescription>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K01-UN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:29:20.393Z</lastUpdated>
  </row>
</eudamedExport>