<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06931747856299</udiDi>
    <basicUdiDi>69317478SD000003GG</basicUdiDi>
    <tradeName>Side Drape</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xuchang Zhengde Environstar Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009427</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020199</emdnCode>
    <emdnDescription>SURGICAL DRAPES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCB1022SA</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:12.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747856329</udiDi>
    <basicUdiDi>69317478SD000003GG</basicUdiDi>
    <tradeName>Fluid collection pouch</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xuchang Zhengde Environstar Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009427</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020199</emdnCode>
    <emdnDescription>SURGICAL DRAPES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCB1023SA</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:12.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747856350</udiDi>
    <basicUdiDi>69317478SD000003GG</basicUdiDi>
    <tradeName>Fluid collection pouch</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xuchang Zhengde Environstar Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009427</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020199</emdnCode>
    <emdnDescription>SURGICAL DRAPES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCB1024SA</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:12.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747856381</udiDi>
    <basicUdiDi>69317478SD000003GG</basicUdiDi>
    <tradeName>Fluid collection pouch</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xuchang Zhengde Environstar Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009427</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020199</emdnCode>
    <emdnDescription>SURGICAL DRAPES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCB1025SA</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:12.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747856770</udiDi>
    <basicUdiDi>69317478SD000003GG</basicUdiDi>
    <tradeName>BNS Extrusion laminate roll, PRIMARY 90cmx50m</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xuchang Zhengde Environstar Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009427</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020199</emdnCode>
    <emdnDescription>SURGICAL DRAPES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>93968-00</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:12.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747858002</udiDi>
    <basicUdiDi>69317478SD000003GG</basicUdiDi>
    <tradeName>Table Cover, PRIMARY 150x210cm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xuchang Zhengde Environstar Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009427</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020199</emdnCode>
    <emdnDescription>SURGICAL DRAPES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63886-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:12.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747858088</udiDi>
    <basicUdiDi>69317478SD000003GG</basicUdiDi>
    <tradeName>BNS Adhesive OP-Towel, PRIMARY 75x75cm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xuchang Zhengde Environstar Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009427</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020199</emdnCode>
    <emdnDescription>SURGICAL DRAPES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>93990-00</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:12.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747858095</udiDi>
    <basicUdiDi>69317478SD000003GG</basicUdiDi>
    <tradeName>BNS Adhesive OP-Towel, PRIMARY 100x75cm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xuchang Zhengde Environstar Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009427</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020199</emdnCode>
    <emdnDescription>SURGICAL DRAPES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>93991-00</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:12.027Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747858101</udiDi>
    <basicUdiDi>69317478SD000003GG</basicUdiDi>
    <tradeName>BNS Adhesive OP-Towel, PRIMARY 100x100cm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xuchang Zhengde Environstar Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009427</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020199</emdnCode>
    <emdnDescription>SURGICAL DRAPES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>93992-00</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:12.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747858125</udiDi>
    <basicUdiDi>69317478SD000003GG</basicUdiDi>
    <tradeName>Lithotomy Leggings, PRIMARY 75x120cm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xuchang Zhengde Environstar Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009427</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020199</emdnCode>
    <emdnDescription>SURGICAL DRAPES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63850-01</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:11.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747858156</udiDi>
    <basicUdiDi>69317478SD000003GG</basicUdiDi>
    <tradeName>Lithotomy Leggings, PRIMARY 75x150cm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xuchang Zhengde Environstar Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009427</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020199</emdnCode>
    <emdnDescription>SURGICAL DRAPES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63851-01</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:11.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747858187</udiDi>
    <basicUdiDi>69317478SD000003GG</basicUdiDi>
    <tradeName>Armrest Cover, PRIMARY 35x73cm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xuchang Zhengde Environstar Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009427</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020199</emdnCode>
    <emdnDescription>SURGICAL DRAPES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63817-01</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:11.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699243181649</udiDi>
    <basicUdiDi>B-08699243181649</basicUdiDi>
    <tradeName>STERILE STANDARD SURGICAL GOWN SMS XX LARGE</tradeName>
    <deviceName>STERILE STANDARD SURGICAL GOWN SMS XX LARGE</deviceName>
    <manufacturerName>OPTİMAL SAĞLIK ÜRÜN. SAN. VE DIŞ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000021855</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T020199</emdnCode>
    <emdnDescription>SURGICAL DRAPES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSG0304005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:50:41.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699243181632</udiDi>
    <basicUdiDi>B-08699243181632</basicUdiDi>
    <tradeName>STERILE STANDARD SURGICAL GOWN SMS X LARGE</tradeName>
    <deviceName>STERILE STANDARD SURGICAL GOWN SMS X LARGE</deviceName>
    <manufacturerName>OPTİMAL SAĞLIK ÜRÜN. SAN. VE DIŞ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000021855</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T020199</emdnCode>
    <emdnDescription>SURGICAL DRAPES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSG0304004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:50:40.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699243181625</udiDi>
    <basicUdiDi>B-08699243181625</basicUdiDi>
    <tradeName>STERILE STANDARD SURGICAL GOWN SMS LARGE</tradeName>
    <deviceName>STERILE STANDARD SURGICAL GOWN SMS LARGE</deviceName>
    <manufacturerName>OPTİMAL SAĞLIK ÜRÜN. SAN. VE DIŞ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000021855</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T020199</emdnCode>
    <emdnDescription>SURGICAL DRAPES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSG0304003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:50:39.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699243181618</udiDi>
    <basicUdiDi>B-08699243181618</basicUdiDi>
    <tradeName>STERILE STANDARD SURGICAL GOWN SMS MEDIUM</tradeName>
    <deviceName>STERILE STANDARD SURGICAL GOWN SMS MEDIUM</deviceName>
    <manufacturerName>OPTİMAL SAĞLIK ÜRÜN. SAN. VE DIŞ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000021855</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T020199</emdnCode>
    <emdnDescription>SURGICAL DRAPES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSG0304002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:50:38.768Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699243181601</udiDi>
    <basicUdiDi>B-08699243181601</basicUdiDi>
    <tradeName>STERILE STANDARD SURGICAL GOWN SMS SMALL</tradeName>
    <deviceName>STERILE STANDARD SURGICAL GOWN SMS SMALL</deviceName>
    <manufacturerName>OPTİMAL SAĞLIK ÜRÜN. SAN. VE DIŞ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000021855</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T020199</emdnCode>
    <emdnDescription>SURGICAL DRAPES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSG0304001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:50:34.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699243180499</udiDi>
    <basicUdiDi>B-08699243180499</basicUdiDi>
    <tradeName>STERILE FULL REINFORCED SURGICAL GOWN SMS XX LARGE</tradeName>
    <deviceName>STERILE FULL REINFORCED SURGICAL GOWN SMS XX LARGE</deviceName>
    <manufacturerName>OPTİMAL SAĞLIK ÜRÜN. SAN. VE DIŞ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000021855</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T020199</emdnCode>
    <emdnDescription>SURGICAL DRAPES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSG0104005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:50:33.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699243180482</udiDi>
    <basicUdiDi>B-08699243180482</basicUdiDi>
    <tradeName>STERILE FULL REINFORCED SURGICAL GOWN SMS X LARGE</tradeName>
    <deviceName>STERILE FULL REINFORCED SURGICAL GOWN SMS X LARGE</deviceName>
    <manufacturerName>OPTİMAL SAĞLIK ÜRÜN. SAN. VE DIŞ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000021855</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T020199</emdnCode>
    <emdnDescription>SURGICAL DRAPES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSG0104004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:50:33.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699243180475</udiDi>
    <basicUdiDi>B-08699243180475</basicUdiDi>
    <tradeName>STERILE FULL REINFORCED SURGICAL GOWN SMS LARGE</tradeName>
    <deviceName>STERILE FULL REINFORCED SURGICAL GOWN SMS LARGE</deviceName>
    <manufacturerName>OPTİMAL SAĞLIK ÜRÜN. SAN. VE DIŞ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000021855</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T020199</emdnCode>
    <emdnDescription>SURGICAL DRAPES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSG0104003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:50:32.379Z</lastUpdated>
  </row>
</eudamedExport>