<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06931747804221</udiDi>
    <basicUdiDi>69317478SP000020NU</basicUdiDi>
    <tradeName>Extremity 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>A10411BCE</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:01:29.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747804207</udiDi>
    <basicUdiDi>69317478SP000017P7</basicUdiDi>
    <tradeName>Hand 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>A101107SCE</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:01:28.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747804184</udiDi>
    <basicUdiDi>69317478SP000025P6</basicUdiDi>
    <tradeName>Arthroscopy 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>A101106BCE</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:01:27.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747804153</udiDi>
    <basicUdiDi>69317478SD000003GG</basicUdiDi>
    <tradeName>Drape,leggings</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>A27009BCE</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:01:24.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747804139</udiDi>
    <basicUdiDi>69317478SD000001GC</basicUdiDi>
    <tradeName>Drape, Fenestrated, , Oval fenestration, Bi</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>A30009BCE</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:01:23.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747804108</udiDi>
    <basicUdiDi>69317478SD000003GG</basicUdiDi>
    <tradeName>Stockinette, Impervious</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>A22525CE</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:01:22.478Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747804078</udiDi>
    <basicUdiDi>69317478SD000003GG</basicUdiDi>
    <tradeName>Op Tape</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>A3550SLCE</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:01:21.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747804009</udiDi>
    <basicUdiDi>69317478SP000021NW</basicUdiDi>
    <tradeName>Small Interventions 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>A30013BCE</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:01:20.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747803972</udiDi>
    <basicUdiDi>69317478SP000006P2</basicUdiDi>
    <tradeName>Gyn/Cystoscopy 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>A10360BCE</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:01:17.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747803958</udiDi>
    <basicUdiDi>69317478SP000005NY</basicUdiDi>
    <tradeName>Universal Split 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>A10132BCE</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:01:16.478Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747803934</udiDi>
    <basicUdiDi>69317478SP000012NV</basicUdiDi>
    <tradeName>Varicose Vein 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>A10120BCE</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:01:15.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747803910</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>A10115BPCE</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:01:14.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747803897</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>A10115BCE</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:01:11.653Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747803873</udiDi>
    <basicUdiDi>69317478SP000015P3</basicUdiDi>
    <tradeName>TUR Pack 4</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>A101148BPCE</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:01:10.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747803859</udiDi>
    <basicUdiDi>69317478SP000015P3</basicUdiDi>
    <tradeName>TUR Pack 3</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>A101147BPCE</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:01:09.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747803835</udiDi>
    <basicUdiDi>69317478SP000006P2</basicUdiDi>
    <tradeName>Gynecology/Abdominal 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>A101144BPCE</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:01:08.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747803811</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>A101140CE</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:01:06.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747803781</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>A101139CE</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:01:04.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747803736</udiDi>
    <basicUdiDi>69317478EC0000017H</basicUdiDi>
    <tradeName>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>A101133SLCE</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:01:03.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747803705</udiDi>
    <basicUdiDi>69317478SD000003GG</basicUdiDi>
    <tradeName>DRAPE Patient Side .A15211B</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>A101130SCE</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:01:02.086Z</lastUpdated>
  </row>
</eudamedExport>