<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06931747859412</udiDi>
    <basicUdiDi>69317478SP000011NT</basicUdiDi>
    <tradeName>Lithotomy Set, PRIMARY</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>63906-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:29:26.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747859382</udiDi>
    <basicUdiDi>69317478SP000015P3</basicUdiDi>
    <tradeName>Cystoscopy Set, PRIMARY</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>63905-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:29:25.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747859351</udiDi>
    <basicUdiDi>69317478SP000022NY</basicUdiDi>
    <tradeName>Head Turban Set, PRIMARY</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>63904-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:29:24.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747859320</udiDi>
    <basicUdiDi>69317478SP000030NX</basicUdiDi>
    <tradeName>Ophthalmic Set, PRIMARY</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>63902-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:29:23.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747859290</udiDi>
    <basicUdiDi>69317478SP000030NX</basicUdiDi>
    <tradeName>Ophthalmic Set, PRIMARY</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>63901-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:29:20.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747859269</udiDi>
    <basicUdiDi>69317478SP000006P2</basicUdiDi>
    <tradeName>Gynaecology and Cystoscopy Set, PRIMARY</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>63900-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:29:19.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747859238</udiDi>
    <basicUdiDi>69317478SP000015P3</basicUdiDi>
    <tradeName>Perineal Drape + OP-Towel Set, PRIMARY</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>63899-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:29:18.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747859207</udiDi>
    <basicUdiDi>69317478SP000013NX</basicUdiDi>
    <tradeName>Laparotomy Set, PRIMARY Plus</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>63898-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:29:17.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747859177</udiDi>
    <basicUdiDi>69317478SP000015P3</basicUdiDi>
    <tradeName>TUR Set, PRIMARY</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>63897-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:29:14.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747859146</udiDi>
    <basicUdiDi>69317478SP000006P2</basicUdiDi>
    <tradeName>Gynaecology and Cystoscopy Set, PRIMARY</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>63896-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:29:13.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747859115</udiDi>
    <basicUdiDi>69317478SP000004NW</basicUdiDi>
    <tradeName>Plastic Surgery Set, PRIMARY</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>63895-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:29:12.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747859085</udiDi>
    <basicUdiDi>69317478SP000015P3</basicUdiDi>
    <tradeName>TUR Set, PRIMARY Plus</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>63894-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:29:11.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747859054</udiDi>
    <basicUdiDi>69317478SP000005NY</basicUdiDi>
    <tradeName>ENT Set, PRIMARY Plus</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>63893-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:29:10.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747859023</udiDi>
    <basicUdiDi>69317478SP000007P4</basicUdiDi>
    <tradeName>Laparoscopy Set Abdo-Perineal, PRIMARY Plus</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>63892-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:29:07.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747858996</udiDi>
    <basicUdiDi>69317478SP000011NT</basicUdiDi>
    <tradeName>Lithotomy Set, PRIMARY Plus</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>63891-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:29:06.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747858965</udiDi>
    <basicUdiDi>69317478SP000011NT</basicUdiDi>
    <tradeName>Lithotomy Set, PRIMARY Plus</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>63890-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:29:05.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747858934</udiDi>
    <basicUdiDi>69317478SP000005NY</basicUdiDi>
    <tradeName>ENT Set, PRIMARY</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>63888-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:29:04.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747858903</udiDi>
    <basicUdiDi>69317478SP000011NT</basicUdiDi>
    <tradeName>Lithotomy Set, PRIMARY</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>63887-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:29:01.631Z</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>2026-06-24T05:29:00.426Z</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>2026-06-24T05:28:59.228Z</lastUpdated>
  </row>
</eudamedExport>