<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06931747846429</udiDi>
    <basicUdiDi>69317478SSG0000029E</basicUdiDi>
    <tradeName>BNS Surgical Gown Primary Plus HP 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>490101-20</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:33.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747846443</udiDi>
    <basicUdiDi>69317478SSG0000029E</basicUdiDi>
    <tradeName>BNS Surgical Gown Primary Plus HP 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>490102-20</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:33.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747846467</udiDi>
    <basicUdiDi>69317478SSG0000029E</basicUdiDi>
    <tradeName>BNS Surgical Gown Primary Plus HP 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>490103-20</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:33.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747846481</udiDi>
    <basicUdiDi>69317478SSG0000029E</basicUdiDi>
    <tradeName>BNS Surgical Gown Primary Plus HP 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>490104-20</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:32.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747847044</udiDi>
    <basicUdiDi>69317478SSG0000029E</basicUdiDi>
    <tradeName>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>550100-20</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:32.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747847068</udiDi>
    <basicUdiDi>69317478SSG0000029E</basicUdiDi>
    <tradeName>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>550101-20</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:32.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747847082</udiDi>
    <basicUdiDi>69317478SSG0000029E</basicUdiDi>
    <tradeName>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>550102-20</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:32.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747847105</udiDi>
    <basicUdiDi>69317478SSG0000029E</basicUdiDi>
    <tradeName>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>550103-20</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:32.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747847129</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>550104-20</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:32.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747847143</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>550105-20</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:32.885Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747847716</udiDi>
    <basicUdiDi>69317478NSSG00000124</basicUdiDi>
    <tradeName>Surgical gown STANDARD open back L, bulk</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>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B332-02M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:32.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747847723</udiDi>
    <basicUdiDi>69317478NSSG00000124</basicUdiDi>
    <tradeName>Surgical gown STANDARD open back XL, bulk</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>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B333-02M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:32.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747847730</udiDi>
    <basicUdiDi>69317478NSSG00000124</basicUdiDi>
    <tradeName>Surgical gown STANDARD Essentia M, bulk</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>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B322-02M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:32.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747847747</udiDi>
    <basicUdiDi>69317478NSSG00000124</basicUdiDi>
    <tradeName>Standard Essentia OP gowns</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>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B323-02M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:32.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747847754</udiDi>
    <basicUdiDi>69317478NSSG00000124</basicUdiDi>
    <tradeName>Standard Essentia OP gowns</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>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B324-02M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:32.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747847761</udiDi>
    <basicUdiDi>69317478NSSG00000124</basicUdiDi>
    <tradeName>Special Essentia OP gowns</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>T020401</emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B352-02M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:32.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747847778</udiDi>
    <basicUdiDi>69317478NSSG00000124</basicUdiDi>
    <tradeName>Special Essentia OP gowns</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>T020401</emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B353-02M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:32.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747847785</udiDi>
    <basicUdiDi>69317478NSSG00000124</basicUdiDi>
    <tradeName>Special Essentia OP gowns</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>T020401</emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B354-02M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:32.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747848348</udiDi>
    <basicUdiDi>69317478SSG0000019C</basicUdiDi>
    <tradeName>SMS standard surgical gown-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>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z564B124003S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:31.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747848362</udiDi>
    <basicUdiDi>69317478SSG0000029E</basicUdiDi>
    <tradeName>SMS reinforced surgical gown-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>Z564B124003R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:31.888Z</lastUpdated>
  </row>
</eudamedExport>