<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06935491700686</udiDi>
    <basicUdiDi>B-06935491700686</basicUdiDi>
    <tradeName>BIALMED</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Kanghua Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033842</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A020102010202</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM020-22LS</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:48:49.986Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935491700679</udiDi>
    <basicUdiDi>B-06935491700679</basicUdiDi>
    <tradeName>BIALMED</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Kanghua Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033842</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A020102010202</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM010-12LS</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:48:48.786Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935491700662</udiDi>
    <basicUdiDi>B-06935491700662</basicUdiDi>
    <tradeName>BIALMED</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Kanghua Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033842</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A020102010202</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM005-6LS</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:48:47.580Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935491700655</udiDi>
    <basicUdiDi>B-06935491700655</basicUdiDi>
    <tradeName>BIALMED</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Kanghua Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033842</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A020102010202</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM002-2.5LS</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:48:46.410Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935491700648</udiDi>
    <basicUdiDi>B-06935491700648</basicUdiDi>
    <tradeName>BIALMED</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Kanghua Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033842</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A020102010102</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, 2-PIECE LUER CONE, 2-PIECE WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM020-24L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:48:45.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935491700631</udiDi>
    <basicUdiDi>B-06935491700631</basicUdiDi>
    <tradeName>BIALMED</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Kanghua Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033842</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A020102010102</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, 2-PIECE LUER CONE, 2-PIECE WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM010-12L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:48:42.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935491700624</udiDi>
    <basicUdiDi>B-06935491700624</basicUdiDi>
    <tradeName>BIALMED</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Kanghua Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033842</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A020102010102</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, 2-PIECE LUER CONE, 2-PIECE WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM005-6L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:48:41.594Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935491700617</udiDi>
    <basicUdiDi>B-06935491700617</basicUdiDi>
    <tradeName>BIALMED</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Kanghua Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033842</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A020102010102</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, 2-PIECE LUER CONE, 2-PIECE WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM002-3L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:48:40.389Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935491700600</udiDi>
    <basicUdiDi>B-06935491700600</basicUdiDi>
    <tradeName>BIALMED</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Kanghua Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033842</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A020102010102</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, 2-PIECE LUER CONE, 2-PIECE WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM002-2.5L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:48:39.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935491700556</udiDi>
    <basicUdiDi>B-06935491700556</basicUdiDi>
    <tradeName>SAFETY A.T/G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Kanghua Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033842</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>191-10-432</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:48:36.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935491700549</udiDi>
    <basicUdiDi>B-06935491700549</basicUdiDi>
    <tradeName>BIALMED</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Kanghua Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033842</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A020102020102</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM050LLB-2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:48:35.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935491700532</udiDi>
    <basicUdiDi>B-06935491700532</basicUdiDi>
    <tradeName>BIALMED</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Kanghua Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033842</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A020102020102</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM050LL-2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:48:34.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935491700525</udiDi>
    <basicUdiDi>B-06935491700525</basicUdiDi>
    <tradeName>BIALMED</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Kanghua Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033842</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A020102020102</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM003LL</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:48:33.191Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935491700501</udiDi>
    <basicUdiDi>B-06935491700501</basicUdiDi>
    <tradeName>BIALMED</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Kanghua Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033842</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A020102020102</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM030LL</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:48:31.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935491700488</udiDi>
    <basicUdiDi>B-06935491700488</basicUdiDi>
    <tradeName>SAFETTY A.T/G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Kanghua Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033842</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A02010203</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, CATHETER CONE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>191-11-500</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:48:29.601Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935491700471</udiDi>
    <basicUdiDi>B-06935491700471</basicUdiDi>
    <tradeName>SAFETY A.T/G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Kanghua Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033842</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A020102010202</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>191-11-200</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:48:28.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935491700464</udiDi>
    <basicUdiDi>B-06935491700464</basicUdiDi>
    <tradeName>SAFETTY A.T/G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Kanghua Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033842</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A020102010201</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITH NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>191-11-020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:48:27.168Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935491700457</udiDi>
    <basicUdiDi>B-06935491700457</basicUdiDi>
    <tradeName>SAFETTY A.T/G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Kanghua Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033842</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A020102010202</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>191-11-100</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:48:25.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935491700440</udiDi>
    <basicUdiDi>B-06935491700440</basicUdiDi>
    <tradeName>SAFETTY A.T/G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Kanghua Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033842</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A020102010201</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITH NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>191-11-010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:48:23.580Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935491700433</udiDi>
    <basicUdiDi>B-06935491700433</basicUdiDi>
    <tradeName>SAFETTY A.T/G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Kanghua Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033842</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A020102010202</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>191-11-005</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:48:22.373Z</lastUpdated>
  </row>
</eudamedExport>