<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06926365589469</udiDi>
    <basicUdiDi>692636552000682</basicUdiDi>
    <tradeName>Medela</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Longterm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001161</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M04040501</emdnCode>
    <emdnDescription>HYDROGEL DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101046675</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:18:13.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>06926365589476</udiDi>
    <basicUdiDi>692636552000682</basicUdiDi>
    <tradeName>Medela</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Longterm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001161</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M04040501</emdnCode>
    <emdnDescription>HYDROGEL DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101046675</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:18:13.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>06926365589636</udiDi>
    <basicUdiDi>692636552000682</basicUdiDi>
    <tradeName>Medela</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Longterm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001161</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M04040501</emdnCode>
    <emdnDescription>HYDROGEL DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101046683</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:18:13.563Z</lastUpdated>
  </row>
  <row>
    <udiDi>06926365589643</udiDi>
    <basicUdiDi>692636552000682</basicUdiDi>
    <tradeName>Medela</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Longterm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001161</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M04040501</emdnCode>
    <emdnDescription>HYDROGEL DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101046683</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:18:13.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>06926365599871</udiDi>
    <basicUdiDi>692636552001889</basicUdiDi>
    <tradeName>Hydrogel Tube</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Longterm Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001161</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M04040501</emdnCode>
    <emdnDescription>HYDROGEL DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HGD6105E</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:18:12.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>16958868781429</udiDi>
    <basicUdiDi>B-16958868781429</basicUdiDi>
    <tradeName>16958868781429</tradeName>
    <deviceName>Sterile Burn Gel</deviceName>
    <manufacturerName>Roosin Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021163</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04040501</emdnCode>
    <emdnDescription>HYDROGEL DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>503.026007</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:14:14.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>16958868781412</udiDi>
    <basicUdiDi>B-16958868781412</basicUdiDi>
    <tradeName>16958868781412</tradeName>
    <deviceName>Sterile Burn Gel</deviceName>
    <manufacturerName>Roosin Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021163</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04040501</emdnCode>
    <emdnDescription>HYDROGEL DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>503.026005</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:14:13.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>16958868781405</udiDi>
    <basicUdiDi>B-16958868781405</basicUdiDi>
    <tradeName>16958868781405</tradeName>
    <deviceName>Sterile Burn Gel</deviceName>
    <manufacturerName>Roosin Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021163</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04040501</emdnCode>
    <emdnDescription>HYDROGEL DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>503.026004</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:14:09.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>16958868781399</udiDi>
    <basicUdiDi>B-16958868781399</basicUdiDi>
    <tradeName>16958868781399</tradeName>
    <deviceName>Sterile Burn Gel</deviceName>
    <manufacturerName>Roosin Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021163</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04040501</emdnCode>
    <emdnDescription>HYDROGEL DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>503.026003</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:14:09.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>16958868781382</udiDi>
    <basicUdiDi>B-16958868781382</basicUdiDi>
    <tradeName>16958868781382</tradeName>
    <deviceName>Sterile Burn Gel</deviceName>
    <manufacturerName>Roosin Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021163</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04040501</emdnCode>
    <emdnDescription>HYDROGEL DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>503.026002</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:14:08.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>16958868781375</udiDi>
    <basicUdiDi>B-16958868781375</basicUdiDi>
    <tradeName>16958868781375</tradeName>
    <deviceName>Sterile Burn Gel</deviceName>
    <manufacturerName>Roosin Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021163</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04040501</emdnCode>
    <emdnDescription>HYDROGEL DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>403.056005</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:14:07.528Z</lastUpdated>
  </row>
  <row>
    <udiDi>16958868781368</udiDi>
    <basicUdiDi>B-16958868781368</basicUdiDi>
    <tradeName>16958868781368</tradeName>
    <deviceName>Sterile Burn Gel</deviceName>
    <manufacturerName>Roosin Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021163</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04040501</emdnCode>
    <emdnDescription>HYDROGEL DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>403.056002</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:14:03.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>16958868781351</udiDi>
    <basicUdiDi>B-16958868781351</basicUdiDi>
    <tradeName>Sterile hydrogel burn gel</tradeName>
    <deviceName>Sterile Burn Gel</deviceName>
    <manufacturerName>Roosin Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021163</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04040501</emdnCode>
    <emdnDescription>HYDROGEL DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK003</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:14:02.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>16958868781344</udiDi>
    <basicUdiDi>B-16958868781344</basicUdiDi>
    <tradeName>Sterile hydrogel burn dressing</tradeName>
    <deviceName>Sterile Burn Gel</deviceName>
    <manufacturerName>Roosin Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021163</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04040501</emdnCode>
    <emdnDescription>HYDROGEL DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK002</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:14:01.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>16958868781337</udiDi>
    <basicUdiDi>B-16958868781337</basicUdiDi>
    <tradeName>Burn Gel&amp;Dressing Kit</tradeName>
    <deviceName>Sterile Burn Gel</deviceName>
    <manufacturerName>Roosin Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021163</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04040501</emdnCode>
    <emdnDescription>HYDROGEL DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK001</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:14:01.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>16958868781320</udiDi>
    <basicUdiDi>B-16958868781320</basicUdiDi>
    <tradeName>16958868781320</tradeName>
    <deviceName>Sterile Burn Gel</deviceName>
    <manufacturerName>Roosin Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021163</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04040501</emdnCode>
    <emdnDescription>HYDROGEL DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>403.001027</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:13:57.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>16958868781184</udiDi>
    <basicUdiDi>B-16958868781184</basicUdiDi>
    <tradeName>16958868781184</tradeName>
    <deviceName>Sterile Burn Gel</deviceName>
    <manufacturerName>Roosin Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021163</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04040501</emdnCode>
    <emdnDescription>HYDROGEL DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>403.001001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:13:56.330Z</lastUpdated>
  </row>
  <row>
    <udiDi>16958868781160</udiDi>
    <basicUdiDi>B-16958868781160</basicUdiDi>
    <tradeName>16958868781160</tradeName>
    <deviceName>Sterile Burn Gel</deviceName>
    <manufacturerName>Roosin Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021163</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04040501</emdnCode>
    <emdnDescription>HYDROGEL DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>403.001011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:13:55.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>16958868781146</udiDi>
    <basicUdiDi>B-16958868781146</basicUdiDi>
    <tradeName>16958868781146</tradeName>
    <deviceName>Sterile Burn Gel</deviceName>
    <manufacturerName>Roosin Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021163</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04040501</emdnCode>
    <emdnDescription>HYDROGEL DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>403.001009</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:13:54.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>16958868781047</udiDi>
    <basicUdiDi>B-16958868781047</basicUdiDi>
    <tradeName>16958868781047</tradeName>
    <deviceName>Sterile Burn Gels</deviceName>
    <manufacturerName>Roosin Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021163</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04040501</emdnCode>
    <emdnDescription>HYDROGEL DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>403.034006</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:13:49.913Z</lastUpdated>
  </row>
</eudamedExport>