<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06945934606222</udiDi>
    <basicUdiDi>B-06945934606222</basicUdiDi>
    <tradeName>suction catheter, funnel type</tradeName>
    <deviceName>suction catheter, funnel type</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010103</emdnCode>
    <emdnDescription>CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C01-03-FR08N single bag</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:31:34.797Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934606192</udiDi>
    <basicUdiDi>69459346HKZ01NWR</basicUdiDi>
    <tradeName>Redon Suction Bottle</tradeName>
    <deviceName>Redon Suction Bottle</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0601010101</emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH REDON TYPE RIGID CONTAINER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>HK-NS-Z01-400</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:31:33.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934606185</udiDi>
    <basicUdiDi>69459346HKZ01NWR</basicUdiDi>
    <tradeName>Redon Suction Bottle</tradeName>
    <deviceName>Redon Suction Bottle</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0601010101</emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH REDON TYPE RIGID CONTAINER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>HK-NS-Z01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:31:27.178Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934606079</udiDi>
    <basicUdiDi>B-06945934606079</basicUdiDi>
    <tradeName>Suction catheter, funnel type, with side holes</tradeName>
    <deviceName>Suction catheter, funnel type, with side holes</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010103</emdnCode>
    <emdnDescription>CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C01-03-FR18 single bag</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:31:26.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934606062</udiDi>
    <basicUdiDi>B-06945934606062</basicUdiDi>
    <tradeName>Suction catheter, funnel type, with side holes</tradeName>
    <deviceName>Suction catheter, funnel type, with side holes</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010103</emdnCode>
    <emdnDescription>CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C01-03-FR10 single bag</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:31:23.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934606055</udiDi>
    <basicUdiDi>B-06945934606055</basicUdiDi>
    <tradeName>Suction catheter</tradeName>
    <deviceName>Suction catheter, funnel type, with side holes</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010103</emdnCode>
    <emdnDescription>CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C01-03-FR06</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:31:22.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934606048</udiDi>
    <basicUdiDi>B-06945934606048</basicUdiDi>
    <tradeName>Suction catheter, funnel type</tradeName>
    <deviceName>Suction catheter, funnel type</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010103</emdnCode>
    <emdnDescription>CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C01-03-FR18N single bag</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:31:16.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934605911</udiDi>
    <basicUdiDi>B-06945934605911</basicUdiDi>
    <tradeName>vaginal speculum</tradeName>
    <deviceName>vaginal speculum</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-A05-L single bag OPP Medplus</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:31:15.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934605904</udiDi>
    <basicUdiDi>B-06945934605904</basicUdiDi>
    <tradeName>vaginal speculum</tradeName>
    <deviceName>vaginal speculum</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-A05-M single bag OPP Medplus</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:31:14.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934605898</udiDi>
    <basicUdiDi>B-06945934605898</basicUdiDi>
    <tradeName>vaginal speculum</tradeName>
    <deviceName>vaginal speculum</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-A05-S single bag OPP Medplus</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:31:13.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934605522</udiDi>
    <basicUdiDi>B-06945934605522</basicUdiDi>
    <tradeName>Rectal tube</tradeName>
    <deviceName>Rectal tube</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G020301</emdnCode>
    <emdnDescription>RECTAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C05</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:31:05.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934605270</udiDi>
    <basicUdiDi>B-06945934605270</basicUdiDi>
    <tradeName>vaginal speculum</tradeName>
    <deviceName>vaginal speculum French type</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-A06-XS OPP single bag</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:31:04.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934605232</udiDi>
    <basicUdiDi>B-06945934605232</basicUdiDi>
    <tradeName>Suction catheter, funnel type, with side holes</tradeName>
    <deviceName>Suction catheter, funnel type, with side holes</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010103</emdnCode>
    <emdnDescription>CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C01-03-FR16 single bag</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:31:03.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934605225</udiDi>
    <basicUdiDi>B-06945934605225</basicUdiDi>
    <tradeName>Suction catheter, funnel type, with side holes</tradeName>
    <deviceName>Suction catheter, funnel type, with side holes</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010103</emdnCode>
    <emdnDescription>CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C01-03-FR14 single bag</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:31:02.127Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934605218</udiDi>
    <basicUdiDi>B-06945934605218</basicUdiDi>
    <tradeName>Suction catheter, funnel type, with side holes</tradeName>
    <deviceName>Suction catheter, funnel type, with side holes</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010103</emdnCode>
    <emdnDescription>CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C01-03-FR12 single bag</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:30:56.009Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934604884</udiDi>
    <basicUdiDi>B-06945934604884</basicUdiDi>
    <tradeName>vaginal speculum</tradeName>
    <deviceName>Vaginal speculum</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-A06-XXS OPP INVISIO</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:30:55.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934604877</udiDi>
    <basicUdiDi>B-06945934604877</basicUdiDi>
    <tradeName>vaginal speculum</tradeName>
    <deviceName>vaginal speculum</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-A06-XS OPP INVISIO</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:30:53.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934604860</udiDi>
    <basicUdiDi>B-06945934604860</basicUdiDi>
    <tradeName>vaginal speculum</tradeName>
    <deviceName>vaginal speculum</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-A06-S OPP INVISIO</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:30:52.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934604853</udiDi>
    <basicUdiDi>B-06945934604853</basicUdiDi>
    <tradeName>vaginal speculum</tradeName>
    <deviceName>vaginal speculum</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-A06-M OPP INVISIO</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:30:46.763Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934604846</udiDi>
    <basicUdiDi>B-06945934604846</basicUdiDi>
    <tradeName>vaginal speculum</tradeName>
    <deviceName>vaginal speculum</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-A06-M-LONG OPP INVISIO</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:30:45.244Z</lastUpdated>
  </row>
</eudamedExport>