<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06951641900232</udiDi>
    <basicUdiDi>69516419P106PR</basicUdiDi>
    <tradeName>Silicone Scar Sheet</tradeName>
    <deviceName>Silicone Scar Sheet</deviceName>
    <manufacturerName>Changsha Hairun Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018236</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M04040702</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C section 16×4mm</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:21:35.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945296012358</udiDi>
    <basicUdiDi>69452960SiFoDress00A77</basicUdiDi>
    <tradeName>06945296012358</tradeName>
    <deviceName>Silicone Foam Dressing</deviceName>
    <manufacturerName>WUHAN HUAWEI TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000014668</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M04040702</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1204</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:09:46.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945296006524</udiDi>
    <basicUdiDi>69452960SiFoDress00B79</basicUdiDi>
    <tradeName>Silicone Foam Dressing</tradeName>
    <deviceName></deviceName>
    <manufacturerName>WUHAN HUAWEI TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000014668</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M04040702</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1204</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:09:45.472Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938056215953</udiDi>
    <basicUdiDi>69380562SD003NC</basicUdiDi>
    <tradeName>GBUK Silicone Foam Border</tradeName>
    <deviceName>silicone dressings</deviceName>
    <manufacturerName>Zhejiang Hongyu Medical Commodity Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008204</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M04040702</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFB075075</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:06:39.914Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938056215915</udiDi>
    <basicUdiDi>69380562SD0001G4</basicUdiDi>
    <tradeName>GBUK Silicone Super Absorber</tradeName>
    <deviceName>silicone dressings</deviceName>
    <manufacturerName>Zhejiang Hongyu Medical Commodity Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008204</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M04040702</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SASB1010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:06:35.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936943400017</udiDi>
    <basicUdiDi>69369434MSGD001YV</basicUdiDi>
    <tradeName>Medical Silicone Gel Dressing</tradeName>
    <deviceName>Medical Silicone Gel Dressing</deviceName>
    <manufacturerName>Henan Huibo Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013580</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M04040702</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5g</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:00:55.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>06926365562264</udiDi>
    <basicUdiDi>69263655200127V</basicUdiDi>
    <tradeName>Innomed</tradeName>
    <deviceName>NPWT silicone foam dressing</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>MDR 2017/745</legislation>
    <emdnCode>M04040702</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SNPWT-1010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:39:59.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>05700002171719</udiDi>
    <basicUdiDi>5700002SCARGROUP3R</basicUdiDi>
    <tradeName>RemeCure Scar (Model:C section 2 sheets)</tradeName>
    <deviceName>Silicone Scar Sheet</deviceName>
    <manufacturerName>Remecure ApS</manufacturerName>
    <manufacturerSrn>DK-MF-000039260</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M04040702</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1719</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:56:12.786Z</lastUpdated>
  </row>
  <row>
    <udiDi>05700002171702</udiDi>
    <basicUdiDi>5700002SCARGROUP3R</basicUdiDi>
    <tradeName>RemeCure Scar (Model:C section 1 sheet)</tradeName>
    <deviceName>Silicone Scar Sheet</deviceName>
    <manufacturerName>Remecure ApS</manufacturerName>
    <manufacturerSrn>DK-MF-000039260</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M04040702</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1702</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:48:03.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>36937935319554</udiDi>
    <basicUdiDi>B-36937935319554</basicUdiDi>
    <tradeName>Cutiderm Wound Contact Layer (9×1.5×14cm)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanghai ISO Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002905</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04040702</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JF0903</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:07:31.191Z</lastUpdated>
  </row>
  <row>
    <udiDi>36937935319547</udiDi>
    <basicUdiDi>B-36937935319547</basicUdiDi>
    <tradeName>Cutiderm Wound Contact Layer (11.5×1×17cm)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanghai ISO Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002905</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M04040702</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JF1086</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:07:29.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936943474384</udiDi>
    <basicUdiDi>69369434MSGD001YV</basicUdiDi>
    <tradeName>Medical Silicone Gel Dressing</tradeName>
    <deviceName>Medical Silicone Gel Dressing</deviceName>
    <manufacturerName>Henan Huibo Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013580</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M04040702</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15g</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-27T22:11:41.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936943495617</udiDi>
    <basicUdiDi>69369434MSGD001YV</basicUdiDi>
    <tradeName>Medical Silicone Gel Dressing</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Henan Huibo Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013580</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M04040702</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8g</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-27T19:59:50.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938056215922</udiDi>
    <basicUdiDi>69380562SD0001G4</basicUdiDi>
    <tradeName>GBUK Silicone Super Absorber</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Hongyu Medical Commodity Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008204</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M04040702</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SASB1020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:28.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938056215939</udiDi>
    <basicUdiDi>69380562SD0001G4</basicUdiDi>
    <tradeName>GBUK Silicone Super Absorber</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Hongyu Medical Commodity Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008204</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M04040702</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SASB2020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:28.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938056215946</udiDi>
    <basicUdiDi>69380562SD0001G4</basicUdiDi>
    <tradeName>GBUK Silicone Super Absorber</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Hongyu Medical Commodity Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008204</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M04040702</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SASB2030</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:28.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938056215960</udiDi>
    <basicUdiDi>69380562SD003NC</basicUdiDi>
    <tradeName>GBUK Silicone Foam Border</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Hongyu Medical Commodity Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008204</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M04040702</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFB1010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:28.180Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938056215977</udiDi>
    <basicUdiDi>69380562SD003NC</basicUdiDi>
    <tradeName>GBUK Silicone Foam Border</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Hongyu Medical Commodity Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008204</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M04040702</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFB125125</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:28.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938056215984</udiDi>
    <basicUdiDi>69380562SD003NC</basicUdiDi>
    <tradeName>GBUK Silicone Foam Border</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Hongyu Medical Commodity Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008204</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M04040702</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFB1515</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:28.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938056215991</udiDi>
    <basicUdiDi>69380562SD003NC</basicUdiDi>
    <tradeName>GBUK Silicone Foam Border</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Hongyu Medical Commodity Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008204</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M04040702</emdnCode>
    <emdnDescription>SILICONE DRESSINGS, COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFB2020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:28.122Z</lastUpdated>
  </row>
</eudamedExport>