<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06931747822218</udiDi>
    <basicUdiDi>69317478EC0000017H</basicUdiDi>
    <tradeName>DRAPE FLUORO 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-7316</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:31:46.538Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747823772</udiDi>
    <basicUdiDi>69317478EC0000017H</basicUdiDi>
    <tradeName>Equipment 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>ZD20220602</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:31:46.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747827350</udiDi>
    <basicUdiDi>69317478EC0000017H</basicUdiDi>
    <tradeName>Clear plastic equipment cover 91x102cm</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-7320</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:31:43.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747827374</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-7328</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:31:42.978Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747828890</udiDi>
    <basicUdiDi>69317478EC0000017H</basicUdiDi>
    <tradeName>DRAPE FLUORO 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-7336</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:31:24.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747829897</udiDi>
    <basicUdiDi>69317478EC0000017H</basicUdiDi>
    <tradeName>Light 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-7625</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:31:24.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747830282</udiDi>
    <basicUdiDi>69317478EC0000017H</basicUdiDi>
    <tradeName>Ultrasound probe 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-7621</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:31:12.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747833764</udiDi>
    <basicUdiDi>69317478EC0000017H</basicUdiDi>
    <tradeName>Equipment 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-7315</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:31:11.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747835942</udiDi>
    <basicUdiDi>69317478EC0000017H</basicUdiDi>
    <tradeName>C-arm drape haft size 117x183cm</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>MECHANICAL ARMS COVERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63048-00</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:31:09.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747838202</udiDi>
    <basicUdiDi>69317478EC0000017H</basicUdiDi>
    <tradeName>TUBE 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>180020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:31:08.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747838233</udiDi>
    <basicUdiDi>69317478EC0000017H</basicUdiDi>
    <tradeName>TUBE 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>180025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:31:08.549Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747838264</udiDi>
    <basicUdiDi>69317478EC0000017H</basicUdiDi>
    <tradeName>Banded bag</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>180050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:31:08.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747838295</udiDi>
    <basicUdiDi>69317478EC0000017H</basicUdiDi>
    <tradeName>Banded bag</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>180055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:31:08.510Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747841837</udiDi>
    <basicUdiDi>69317478EC0000017H</basicUdiDi>
    <tradeName>Banden bag</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>MCB3001SA</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:31:07.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747841851</udiDi>
    <basicUdiDi>69317478EC0000017H</basicUdiDi>
    <tradeName>Banden bag</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>MCB3003SA</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:31:06.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747841875</udiDi>
    <basicUdiDi>69317478EC0000017H</basicUdiDi>
    <tradeName>Banden bag</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>MCB3004SA</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:31:06.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747856114</udiDi>
    <basicUdiDi>69317478EC0000017H</basicUdiDi>
    <tradeName>Tube 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>MCB3005SA</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:29.293Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698918079076</udiDi>
    <basicUdiDi>B-08698918079076</basicUdiDi>
    <tradeName>08698918079076</tradeName>
    <deviceName>Disposable Sterile Betadine Sponge</deviceName>
    <manufacturerName>3 TEKS TEKSTİL GIDA İTH.İHR.SAN. VE TİC.LTD.ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000032256</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>238-00-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:14:11.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698918078697</udiDi>
    <basicUdiDi>B-08698918078697</basicUdiDi>
    <tradeName>08698918078697</tradeName>
    <deviceName>STERILIZATION POUCH 35*50 CM</deviceName>
    <manufacturerName>3 TEKS TEKSTİL GIDA İTH.İHR.SAN. VE TİC.LTD.ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000032256</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>304-01-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:14:01.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698918078680</udiDi>
    <basicUdiDi>B-08698918078680</basicUdiDi>
    <tradeName>08698918078680</tradeName>
    <deviceName>STERILIZATION POUCH 30*40 CM</deviceName>
    <manufacturerName>3 TEKS TEKSTİL GIDA İTH.İHR.SAN. VE TİC.LTD.ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000032256</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>304-01-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:14:00.348Z</lastUpdated>
  </row>
</eudamedExport>