<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>16974802580255</udiDi>
    <basicUdiDi>B-16974802580255</basicUdiDi>
    <tradeName>EXCELLENT GREEN SHIELD</tradeName>
    <deviceName>Sterile Non-woven and PE Composited Surgical Gowns</deviceName>
    <manufacturerName>Xinle Huabao Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008893</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T020402</emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ⅱ型（XXXL）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:05:16.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>16974802580248</udiDi>
    <basicUdiDi>B-16974802580248</basicUdiDi>
    <tradeName>EXCELLENT GREEN SHIELD</tradeName>
    <deviceName>Sterile Non-woven and PE Composited Surgical Gowns</deviceName>
    <manufacturerName>Xinle Huabao Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008893</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T020402</emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ⅱ型（XXL）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:05:15.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>16974802580231</udiDi>
    <basicUdiDi>B-16974802580231</basicUdiDi>
    <tradeName>EXCELLENT GREEN SHIELD</tradeName>
    <deviceName>Sterile Non-woven and PE Composited Surgical Gowns</deviceName>
    <manufacturerName>Xinle Huabao Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008893</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T020402</emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ⅱ型（XL）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:05:13.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>16974802580224</udiDi>
    <basicUdiDi>B-16974802580224</basicUdiDi>
    <tradeName>EXCELLENT GREEN SHIELD</tradeName>
    <deviceName>Sterile Non-woven and PE Composited Surgical Gowns</deviceName>
    <manufacturerName>Xinle Huabao Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008893</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T020402</emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ⅱ型（L）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:05:11.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>16974802580200</udiDi>
    <basicUdiDi>B-16974802580200</basicUdiDi>
    <tradeName>EXCELLENT GREEN SHIELD</tradeName>
    <deviceName>Sterile Non-woven and PE Composited Surgical Gowns</deviceName>
    <manufacturerName>Xinle Huabao Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008893</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T020402</emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ⅱ型（S）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:05:09.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>16974802580217</udiDi>
    <basicUdiDi>B-16974802580217</basicUdiDi>
    <tradeName>EXCELLENT GREEN SHIELD</tradeName>
    <deviceName>Sterile Non-woven and PE Composited Surgical Gowns</deviceName>
    <manufacturerName>Xinle Huabao Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008893</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T020402</emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ⅱ型（M）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:05:07.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>06161116346087</udiDi>
    <basicUdiDi>616111634SG000002S6</basicUdiDi>
    <tradeName>BGEcare</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FULLCARE (KENYA) MEDICAL SEZ LIMITED</manufacturerName>
    <manufacturerSrn>KE-MF-000040179</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>Z564B124001R-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:57:30.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>06161116346100</udiDi>
    <basicUdiDi>616111634SG000002S6</basicUdiDi>
    <tradeName>BGEcare</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FULLCARE (KENYA) MEDICAL SEZ LIMITED</manufacturerName>
    <manufacturerSrn>KE-MF-000040179</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>Z564B124002R-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:57:30.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>06161116347039</udiDi>
    <basicUdiDi>616111634SG000002S6</basicUdiDi>
    <tradeName>INDAS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FULLCARE (KENYA) MEDICAL SEZ LIMITED</manufacturerName>
    <manufacturerSrn>KE-MF-000040179</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>1291010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:57:30.522Z</lastUpdated>
  </row>
  <row>
    <udiDi>06161116347060</udiDi>
    <basicUdiDi>616111634SG000002S6</basicUdiDi>
    <tradeName>INDAS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FULLCARE (KENYA) MEDICAL SEZ LIMITED</manufacturerName>
    <manufacturerSrn>KE-MF-000040179</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>1291011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:57:30.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>06161116347091</udiDi>
    <basicUdiDi>616111634SG000002S6</basicUdiDi>
    <tradeName>INDAS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FULLCARE (KENYA) MEDICAL SEZ LIMITED</manufacturerName>
    <manufacturerSrn>KE-MF-000040179</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>1291012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:57:30.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>06161116347121</udiDi>
    <basicUdiDi>616111634SG000002S6</basicUdiDi>
    <tradeName>INDAS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FULLCARE (KENYA) MEDICAL SEZ LIMITED</manufacturerName>
    <manufacturerSrn>KE-MF-000040179</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>1291013</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:57:30.465Z</lastUpdated>
  </row>
  <row>
    <udiDi>06161116347169</udiDi>
    <basicUdiDi>616111634SG000002S6</basicUdiDi>
    <tradeName>INDAS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FULLCARE (KENYA) MEDICAL SEZ LIMITED</manufacturerName>
    <manufacturerSrn>KE-MF-000040179</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>1291014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:57:30.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>06161116347725</udiDi>
    <basicUdiDi>616111634SG000002S6</basicUdiDi>
    <tradeName>INDAS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FULLCARE (KENYA) MEDICAL SEZ LIMITED</manufacturerName>
    <manufacturerSrn>KE-MF-000040179</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>1291015</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:57:30.293Z</lastUpdated>
  </row>
  <row>
    <udiDi>06161116347756</udiDi>
    <basicUdiDi>616111634SG000002S6</basicUdiDi>
    <tradeName>INDAS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FULLCARE (KENYA) MEDICAL SEZ LIMITED</manufacturerName>
    <manufacturerSrn>KE-MF-000040179</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>1291016</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:57:30.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>06161116347787</udiDi>
    <basicUdiDi>616111634SG000002S6</basicUdiDi>
    <tradeName>INDAS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FULLCARE (KENYA) MEDICAL SEZ LIMITED</manufacturerName>
    <manufacturerSrn>KE-MF-000040179</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>1291017</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:57:30.259Z</lastUpdated>
  </row>
  <row>
    <udiDi>06161116347817</udiDi>
    <basicUdiDi>616111634SG000002S6</basicUdiDi>
    <tradeName>INDAS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FULLCARE (KENYA) MEDICAL SEZ LIMITED</manufacturerName>
    <manufacturerSrn>KE-MF-000040179</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>1291018</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:57:30.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>06161116348142</udiDi>
    <basicUdiDi>616111634SG000002S6</basicUdiDi>
    <tradeName>Abena</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FULLCARE (KENYA) MEDICAL SEZ LIMITED</manufacturerName>
    <manufacturerSrn>KE-MF-000040179</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>1999914261</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:57:29.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>06161116348166</udiDi>
    <basicUdiDi>616111634SG000002S6</basicUdiDi>
    <tradeName>Abena</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FULLCARE (KENYA) MEDICAL SEZ LIMITED</manufacturerName>
    <manufacturerSrn>KE-MF-000040179</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>1999914263</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:57:29.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>06161116348180</udiDi>
    <basicUdiDi>616111634SG000002S6</basicUdiDi>
    <tradeName>Abena</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FULLCARE (KENYA) MEDICAL SEZ LIMITED</manufacturerName>
    <manufacturerSrn>KE-MF-000040179</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>1999914265</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:57:29.907Z</lastUpdated>
  </row>
</eudamedExport>