<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06945934603177</udiDi>
    <basicUdiDi>B-06945934603177</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 single bag Blister Medplus</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:29:56.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934603160</udiDi>
    <basicUdiDi>B-06945934603160</basicUdiDi>
    <tradeName>urine drainage bag</tradeName>
    <deviceName>Urine drainage bag</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>A06030301</emdnCode>
    <emdnDescription>URINE COLLECTION BAGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HKB03STN</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:29:54.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934603061</udiDi>
    <basicUdiDi>B-06945934603061</basicUdiDi>
    <tradeName>endotracheal tube normal uncuffed</tradeName>
    <deviceName>endotracheal tube, normal, uncuffed</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>R01030101</emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES, CUFFLESS, NOT REINFORCED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-E01</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:29:47.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934603054</udiDi>
    <basicUdiDi>B-06945934603054</basicUdiDi>
    <tradeName>endotracheal tube normal cuffed</tradeName>
    <deviceName>endotracheal tube normal cuffed</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>R01030201</emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES, CUFFED, NOT REINFORCED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-E02</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:29:46.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934603016</udiDi>
    <basicUdiDi>69459346udbGQ</basicUdiDi>
    <tradeName>Urine drainage bag</tradeName>
    <deviceName>Urine Drainage Bag</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>A06030301</emdnCode>
    <emdnDescription>URINE COLLECTION BAGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HKB03NTN</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:29:45.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934602934</udiDi>
    <basicUdiDi>B-06945934602934</basicUdiDi>
    <tradeName>mucus extractor</tradeName>
    <deviceName>mucus extractor</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>A0601010102</emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH RESERVOIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C07</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:29:44.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934602927</udiDi>
    <basicUdiDi>69459346udbGQ</basicUdiDi>
    <tradeName>urine drainage bag</tradeName>
    <deviceName>Urine Drainage Bag</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>A06030301</emdnCode>
    <emdnDescription>URINE COLLECTION BAGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HKB01NPNA</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:29:37.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934602910</udiDi>
    <basicUdiDi>69459346udbGQ</basicUdiDi>
    <tradeName>urine drainage bag</tradeName>
    <deviceName>Urine Drainage Bag</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>A06030301</emdnCode>
    <emdnDescription>URINE COLLECTION BAGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HKB01NPN</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:29:36.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934602415</udiDi>
    <basicUdiDi>B-06945934602415</basicUdiDi>
    <tradeName>nelaton catheter</tradeName>
    <deviceName>nelaton catheter</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>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C02-18</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:29:35.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934602408</udiDi>
    <basicUdiDi>B-06945934602408</basicUdiDi>
    <tradeName>nelaton catheter</tradeName>
    <deviceName>nelaton catheter</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>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C02-16</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:29:34.327Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934602392</udiDi>
    <basicUdiDi>B-06945934602392</basicUdiDi>
    <tradeName>nelaton catheter</tradeName>
    <deviceName>nelaton catheter</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>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C02-14</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:29:28.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934602385</udiDi>
    <basicUdiDi>B-06945934602385</basicUdiDi>
    <tradeName>nelaton catheter</tradeName>
    <deviceName>nelaton catheter</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>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C02-12</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:29:27.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934602378</udiDi>
    <basicUdiDi>B-06945934602378</basicUdiDi>
    <tradeName>nelaton catheter</tradeName>
    <deviceName>nelaton catheter</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>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C02-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:29:26.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934602361</udiDi>
    <basicUdiDi>B-06945934602361</basicUdiDi>
    <tradeName>nelaton catheter</tradeName>
    <deviceName>nelaton catheter</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>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C02-08</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:29:24.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934602354</udiDi>
    <basicUdiDi>B-06945934602354</basicUdiDi>
    <tradeName>nelaton catheter</tradeName>
    <deviceName>nelaton catheter</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>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C02-06</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:29:19.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934602330</udiDi>
    <basicUdiDi>B-06945934602330</basicUdiDi>
    <tradeName>nasal oxygen cannula</tradeName>
    <deviceName>nasal oxygen cannula size: Adult</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>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C08-L</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:29:18.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934602231</udiDi>
    <basicUdiDi>B-06945934602231</basicUdiDi>
    <tradeName>Vaginal speculum, Side screw type, Size L, Single bag</tradeName>
    <deviceName>Vaginal speculum, Side screw type, Size L, Single bag</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-A04-L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:29:16.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934602224</udiDi>
    <basicUdiDi>B-06945934602224</basicUdiDi>
    <tradeName>Vaginal speculum, Side screw type, Size M, Single bag</tradeName>
    <deviceName>Vaginal speculum, Side screw type, Size M, Single bag</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-A04-M</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:29:15.527Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934602217</udiDi>
    <basicUdiDi>B-06945934602217</basicUdiDi>
    <tradeName>Vaginal speculum, Side screw type, Size S, Single bag</tradeName>
    <deviceName>Vaginal speculum, Side screw type, Size S, Single bag</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-A04-S</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:29:09.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934602125</udiDi>
    <basicUdiDi>69459346udbGQ</basicUdiDi>
    <tradeName>Urine drainage bag</tradeName>
    <deviceName>Urine Drainage Bag</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>A06030301</emdnCode>
    <emdnDescription>URINE COLLECTION BAGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HKB04NNN</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:29:07.889Z</lastUpdated>
  </row>
</eudamedExport>