<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>2026-06-24T05:28:58.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747858118</udiDi>
    <basicUdiDi>69317478NEC000001T8</basicUdiDi>
    <tradeName>Leadscreen Cover with Split</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>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>93100-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:28:56.835Z</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>2026-06-24T05:28:54.418Z</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>2026-06-24T05:28:53.242Z</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>2026-06-24T05:28:52.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747858071</udiDi>
    <basicUdiDi>69317478SD000001GC</basicUdiDi>
    <tradeName>BNS Adhesive Aperture Drape, PRIMARY 75x80cm, Aperture 6x15cm</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>T02010101</emdnCode>
    <emdnDescription>INCISION DRAPES, WITHOUT ANTIBACTERIAL AGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>93989-00</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:28:50.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747858064</udiDi>
    <basicUdiDi>69317478SD000002GE</basicUdiDi>
    <tradeName>BNS Abdominal Drape, PRIMARY 115x150cm</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>T020102</emdnCode>
    <emdnDescription>SPECIALISTIC SURGERY DRAPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>93987-00</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:28:48.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747858057</udiDi>
    <basicUdiDi>69317478SD000001GC</basicUdiDi>
    <tradeName>BNS Adhesive Aperture Drape, PRIMARY 50x60cm, Aperture 6x8cm</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>T02010101</emdnCode>
    <emdnDescription>INCISION DRAPES, WITHOUT ANTIBACTERIAL AGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>93986-00</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:28:47.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747858040</udiDi>
    <basicUdiDi>69317478SD000001GC</basicUdiDi>
    <tradeName>BNS Adhesive Aperture Drape, PRIMARY 75x90cm, Aperture 7cm</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>T02010101</emdnCode>
    <emdnDescription>INCISION DRAPES, WITHOUT ANTIBACTERIAL AGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>93985-00</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:28:46.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747858033</udiDi>
    <basicUdiDi>69317478SD000001GC</basicUdiDi>
    <tradeName>BNS Adhesive Aperture Drape, PRIMARY 75x100cm,  Aperture incise 6x12cm</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>T02010101</emdnCode>
    <emdnDescription>INCISION DRAPES, WITHOUT ANTIBACTERIAL AGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>93984-00</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:28:44.830Z</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>2026-06-24T05:28:43.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747857975</udiDi>
    <basicUdiDi>69317478SD000001GC</basicUdiDi>
    <tradeName>Adhesive Aperture Drape, PRIMARY 75x90cm, Aperture 7cm</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>T02010101</emdnCode>
    <emdnDescription>INCISION DRAPES, WITHOUT ANTIBACTERIAL AGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63885-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:28:41.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747857944</udiDi>
    <basicUdiDi>69317478SD000001GC</basicUdiDi>
    <tradeName>Adhesive Aperture Drape, PRIMARY 75x100cm, Aperture incise 6x12cm</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>T02010101</emdnCode>
    <emdnDescription>INCISION DRAPES, WITHOUT ANTIBACTERIAL AGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63884-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:28:40.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747857180</udiDi>
    <basicUdiDi>69317478SD000001GC</basicUdiDi>
    <tradeName>Sterile adhesive aperture 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>T02010101</emdnCode>
    <emdnDescription>INCISION DRAPES, WITHOUT ANTIBACTERIAL AGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1071</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:28:38.813Z</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>2026-06-24T05:28:37.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747856565</udiDi>
    <basicUdiDi>69317478SP000021NW</basicUdiDi>
    <tradeName>Universal pack</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>T0202</emdnCode>
    <emdnDescription>SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCB2021SA</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:28:35.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747856534</udiDi>
    <basicUdiDi>69317478SP000030NX</basicUdiDi>
    <tradeName>ophthalmology set</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>T0202</emdnCode>
    <emdnDescription>SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCB2020SA</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:28:34.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747856503</udiDi>
    <basicUdiDi>69317478SP000006P2</basicUdiDi>
    <tradeName>Gynecology set</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>T0202</emdnCode>
    <emdnDescription>SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCB2019SA</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:28:32.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747856473</udiDi>
    <basicUdiDi>69317478SP000006P2</basicUdiDi>
    <tradeName>Gynecology set</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>T0202</emdnCode>
    <emdnDescription>SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCB2018SA</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:28:31.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747856442</udiDi>
    <basicUdiDi>69317478SP000019PB</basicUdiDi>
    <tradeName>Dilivery set</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>T0202</emdnCode>
    <emdnDescription>SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCB2017SA</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:28:30.422Z</lastUpdated>
  </row>
</eudamedExport>