<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>66920756726312</udiDi>
    <basicUdiDi>69207567ND0001E6</basicUdiDi>
    <tradeName>Urine Bag for Single Use 2000ml  Cross valve</tradeName>
    <deviceName>Urine Bag for Single Use</deviceName>
    <manufacturerName>Jiangxi Hongda Medical Equipment Group Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A06030301</emdnCode>
    <emdnDescription>URINE COLLECTION BAGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U2000T</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:19:44.890Z</lastUpdated>
  </row>
  <row>
    <udiDi>66920756725650</udiDi>
    <basicUdiDi>69207567DJJCST0001YV</basicUdiDi>
    <tradeName>Nitrile TEXTURDE SURFACE S</tradeName>
    <deviceName>Single-use medical examination gloves</deviceName>
    <manufacturerName>Jiangxi Hongda Medical Equipment Group Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01020204</emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E12S</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:19:44.104Z</lastUpdated>
  </row>
  <row>
    <udiDi>66920756725506</udiDi>
    <basicUdiDi>69207567XJJCST0001K4</basicUdiDi>
    <tradeName>Natural Rubber  TEXTURDE SURFACE   XS</tradeName>
    <deviceName>Single-use medical examination gloves</deviceName>
    <manufacturerName>Jiangxi Hongda Medical Equipment Group Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T010201</emdnCode>
    <emdnDescription>LATEX EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E11XS</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:19:42.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>66920756725001</udiDi>
    <basicUdiDi>69207567WKST0001D4</basicUdiDi>
    <tradeName>Single-use Sterile rubber surgical gloves  Textured powder-free 6.5#</tradeName>
    <deviceName>Single-use Sterile rubber surgical gloves</deviceName>
    <manufacturerName>Jiangxi Hongda Medical Equipment Group Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010102</emdnCode>
    <emdnDescription>NON-POWDERED LATEX SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G1165</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:19:40.892Z</lastUpdated>
  </row>
  <row>
    <udiDi>66920756724301</udiDi>
    <basicUdiDi>69207567WG0001JU</basicUdiDi>
    <tradeName>Disposable Stomach Catheter 2.0mm(6Fr)</tradeName>
    <deviceName>Disposable Stomach Catheter</deviceName>
    <manufacturerName>Jiangxi Hongda Medical Equipment Group Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G02020101</emdnCode>
    <emdnDescription>NASOGASTRIC TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WL06</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:19:40.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>66920756723908</udiDi>
    <basicUdiDi>69207567BYG0001KZ</basicUdiDi>
    <tradeName>Nasal oxygen cannula for single use Baby-type</tradeName>
    <deviceName>Nasal oxygen cannula for single use</deviceName>
    <manufacturerName>Jiangxi Hongda Medical Equipment Group Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010201</emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OB</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:19:38.495Z</lastUpdated>
  </row>
  <row>
    <udiDi>66920756722208</udiDi>
    <basicUdiDi>69207567ZKZXG00017P</basicUdiDi>
    <tradeName>Vacuum blood collection tubes for single use   No additive 1ml</tradeName>
    <deviceName>Vacuum blood collection tubes for single use</deviceName>
    <manufacturerName>Jiangxi Hongda Medical Equipment Group Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050101010202</emdnCode>
    <emdnDescription>BLOOD COLLECTION, TUBES WITHOUT ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT1307501ER</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:19:36.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>66920756721607</udiDi>
    <basicUdiDi>69207567SZB0001TQ</basicUdiDi>
    <tradeName>Infusion pump for single use  CBI  100ml  2ml/h</tradeName>
    <deviceName>Infusion pump for single use</deviceName>
    <manufacturerName>Jiangxi Hongda Medical Equipment Group Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CBI100-2</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:19:34.481Z</lastUpdated>
  </row>
  <row>
    <udiDi>66920756721409</udiDi>
    <basicUdiDi>69207567GYZYZSQJFJ0001DX</basicUdiDi>
    <tradeName>High-pressure Angiographic syringes and Accessories for single use</tradeName>
    <deviceName>High-pressure Angiographic syringes and Accessories for single use</deviceName>
    <manufacturerName>Jiangxi Hongda Medical Equipment Group Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010401</emdnCode>
    <emdnDescription>SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CT200MM</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:19:33.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>66920756721317</udiDi>
    <basicUdiDi>69207567GSM0001NA</basicUdiDi>
    <tradeName>Heparin cap for single use GSM-A</tradeName>
    <deviceName>Heparin cap for single use</deviceName>
    <manufacturerName>Jiangxi Hongda Medical Equipment Group Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A070103</emdnCode>
    <emdnDescription>INFUSION TUBING ADAPTERS AND CONNECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GSM-A-T02</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:19:32.076Z</lastUpdated>
  </row>
  <row>
    <udiDi>66920756721003</udiDi>
    <basicUdiDi>69207567YDKZQ0001WZ</basicUdiDi>
    <tradeName>Vagina Dilator for Single Use</tradeName>
    <deviceName>Vagina Dilator for Single Use</deviceName>
    <manufacturerName>Jiangxi Hongda Medical Equipment Group Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZDM</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:19:29.705Z</lastUpdated>
  </row>
  <row>
    <udiDi>66920756719000</udiDi>
    <basicUdiDi>69207567TWXHXL000136</basicUdiDi>
    <tradeName>Blood Tubing Set for Hemodialysis 20-A</tradeName>
    <deviceName>Blood Tubing Set for Hemodialysis</deviceName>
    <manufacturerName>Jiangxi Hongda Medical Equipment Group Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F020104</emdnCode>
    <emdnDescription>REINFUSION DIALYSIS LINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XU20-A</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:19:28.092Z</lastUpdated>
  </row>
  <row>
    <udiDi>66920756718508</udiDi>
    <basicUdiDi>69207567KXXWTXQ00028Y</basicUdiDi>
    <tradeName>Hollow fiber hemodialyzer low-flux HD-10L</tradeName>
    <deviceName>Hollow fiber hemodialyzer low-flux</deviceName>
    <manufacturerName>Jiangxi Hongda Medical Equipment Group Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F01060103</emdnCode>
    <emdnDescription>DIALYSERS - UFC &lt; 18 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HD-10L-001</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:19:27.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>66920756718003</udiDi>
    <basicUdiDi>69207567KXXWTXQ00018W</basicUdiDi>
    <tradeName>Hollow Fiber Hemodialyzer</tradeName>
    <deviceName>Hollow Fiber Hemodialyzer</deviceName>
    <manufacturerName>Jiangxi Hongda Medical Equipment Group Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>F01060203</emdnCode>
    <emdnDescription>DIALYSERS - UFC = 18 - 35 ml/h/mmHg, SYNTHETIC MEMBRANES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HD-10H-001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:19:25.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>66920756717303</udiDi>
    <basicUdiDi>69207567DJMCCZ0001W8</basicUdiDi>
    <tradeName>A.V. fistula needle sets for single use  Revolving wing  2.1mm(14G)    White water stop clip</tradeName>
    <deviceName>A.V. fistula needle sets for single use</deviceName>
    <manufacturerName>Jiangxi Hongda Medical Equipment Group Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A14R</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:19:23.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>66920756717006</udiDi>
    <basicUdiDi>69207567YDSBYZT0001QP</basicUdiDi>
    <tradeName>Insulin pen needle for single use  0.33mm(29G)×4mm</tradeName>
    <deviceName>Insulin pen needle for single use</deviceName>
    <manufacturerName>Jiangxi Hongda Medical Equipment Group Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010202</emdnCode>
    <emdnDescription>HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NI29</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:19:21.672Z</lastUpdated>
  </row>
  <row>
    <udiDi>66920756716016</udiDi>
    <basicUdiDi>69207567CXZ001RJ</basicUdiDi>
    <tradeName>Blood collection needles for single use</tradeName>
    <deviceName>Blood collection needles for single use</deviceName>
    <manufacturerName>Jiangxi Hongda Medical Equipment Group Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01010502</emdnCode>
    <emdnDescription>NEEDLES FOR COLLECTION UNDER VACCUM, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VP2238</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:19:20.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>66920756717204</udiDi>
    <basicUdiDi>69207567YKZ0001Z3</basicUdiDi>
    <tradeName>Sterile Single-use Dental Injection Needles  0.4mm(27G)</tradeName>
    <deviceName>Sterile Single-use Dental Injection Needles</deviceName>
    <manufacturerName>Jiangxi Hongda Medical Equipment Group Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A010699</emdnCode>
    <emdnDescription>DENTISTRY NEEDLES AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Y2735</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:19:19.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>66920756715385</udiDi>
    <basicUdiDi>69207567JMLZZ0004VD</basicUdiDi>
    <tradeName>IV Cannula for single use  Straight-Through Type (Butterfly Type) 0.6mm×16mm(26G×0.63in)</tradeName>
    <deviceName>IV Cannula for single use</deviceName>
    <manufacturerName>Jiangxi Hongda Medical Equipment Group Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0101010101</emdnCode>
    <emdnDescription>PERIPHERAL I.V. CATHETERS, W/O SAFETY SYSTEMS, WITH INJECTION VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CB26</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:19:05.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>66920756715002</udiDi>
    <basicUdiDi>69207567FZCJMSYZ0001JC</basicUdiDi>
    <tradeName>Safety scalp vein sets for single use  0.6mm(23G)</tradeName>
    <deviceName>Safety scalp vein sets for single use</deviceName>
    <manufacturerName>Jiangxi Hongda Medical Equipment Group Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01010201</emdnCode>
    <emdnDescription>BUTTERFLY NEEDLES, WITH SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA26L</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:19:01.612Z</lastUpdated>
  </row>
</eudamedExport>