<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06931747821495</udiDi>
    <basicUdiDi>69317478SSG0000029E</basicUdiDi>
    <tradeName>BNS Surgical Gown Primary Plus Fabric Reinforced XXL-XL</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>T020402</emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>450105-00</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:08:25.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747821488</udiDi>
    <basicUdiDi>69317478SSG0000029E</basicUdiDi>
    <tradeName>BNS Surgical Gown Primary Plus Fabric Reinforced XXL-L</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>T020402</emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>450104-00</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:08:24.064Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747821471</udiDi>
    <basicUdiDi>69317478SSG0000029E</basicUdiDi>
    <tradeName>BNS Surgical Gown Primary Plus Fabric Reinforced XL-L</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>T020402</emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>450103-00</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:08:22.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747821464</udiDi>
    <basicUdiDi>69317478SSG0000029E</basicUdiDi>
    <tradeName>BNS Surgical Gown Primary Plus Fabric Reinforced XL</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>T020402</emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>450102-00</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:08:21.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747821457</udiDi>
    <basicUdiDi>69317478SSG0000029E</basicUdiDi>
    <tradeName>BNS Surgical Gown Primary Plus Fabric Reinforced L-L</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>T020402</emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>450101-00</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:08:20.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747821440</udiDi>
    <basicUdiDi>69317478SSG0000029E</basicUdiDi>
    <tradeName>BNS Surgical Gown Primary Plus Fabric Reinforced L</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>T020402</emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>450100-00</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:08:19.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747821433</udiDi>
    <basicUdiDi>69317478SSG0000029E</basicUdiDi>
    <tradeName>Surgical Gown Primary Plus Fabric Reinforced XXL-XL</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>T020402</emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>550105-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:08:18.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747821419</udiDi>
    <basicUdiDi>69317478SSG0000029E</basicUdiDi>
    <tradeName>Surgical Gown Primary Plus Fabric Reinforced XXL-L</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>T020402</emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>550104-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:08:16.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747821327</udiDi>
    <basicUdiDi>69317478NSD00000146</basicUdiDi>
    <tradeName>Perineal Cover</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>93062-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:08:15.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747821310</udiDi>
    <basicUdiDi>69317478NSD00000146</basicUdiDi>
    <tradeName>TUR 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>T020102</emdnCode>
    <emdnDescription>SPECIALISTIC SURGERY DRAPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>93081-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:08:14.481Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747821150</udiDi>
    <basicUdiDi>69317478EC0000017H</basicUdiDi>
    <tradeName>DRAPE BASIN COVER</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>RFD-7603</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:08:13.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747821136</udiDi>
    <basicUdiDi>69317478SD000002GE</basicUdiDi>
    <tradeName>Ophthalmic drape 130x140cm</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>RFD-7616</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:08:12.074Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747821112</udiDi>
    <basicUdiDi>69317478EC0000017H</basicUdiDi>
    <tradeName>Fluoroscope cover</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>RFD-7326</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:08:10.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747821099</udiDi>
    <basicUdiDi>69317478EC0000017H</basicUdiDi>
    <tradeName>Fluoroscope cover 36cm</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>RFD-7323</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:08:09.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747821037</udiDi>
    <basicUdiDi>69317478SP000016P5</basicUdiDi>
    <tradeName>Caesarean 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>RFDP03-7100</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:08:07.267Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747821013</udiDi>
    <basicUdiDi>69317478SD000003GG</basicUdiDi>
    <tradeName>Baby wrap 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>RFD-7619</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:08:06.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747820993</udiDi>
    <basicUdiDi>69317478EC0000017H</basicUdiDi>
    <tradeName>DRAPE CHAIR ARM COVER</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>RFD-7605</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:08:04.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747820955</udiDi>
    <basicUdiDi>69317478EC0000017H</basicUdiDi>
    <tradeName>DRAPE ULTRASOUND COVER</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>RFD-7322</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:08:03.679Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747820566</udiDi>
    <basicUdiDi>69317478SD000003GG</basicUdiDi>
    <tradeName>Drape Utility 180 x 180cm N/A SPP</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>RFD-7133</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:08:02.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747820931</udiDi>
    <basicUdiDi>69317478EC0000017H</basicUdiDi>
    <tradeName>DRAPE HANDLE COVER</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>RFD-7280</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:08:01.273Z</lastUpdated>
  </row>
</eudamedExport>