<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06945934602118</udiDi>
    <basicUdiDi>B-06945934602118</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-L OPP single bag</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:29:06.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934602101</udiDi>
    <basicUdiDi>B-06945934602101</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-M OPP single bag</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:29:05.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934602095</udiDi>
    <basicUdiDi>B-06945934602095</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-S OPP single bag</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:28:59.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934602088</udiDi>
    <basicUdiDi>B-06945934602088</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-XXS OPP single bag</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:28:58.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934602071</udiDi>
    <basicUdiDi>B-06945934602071</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 Huankang</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:28:57.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934602064</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>2026-06-27T20:28:56.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934602040</udiDi>
    <basicUdiDi>B-06945934602040</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-A08-L single bag OPP Medplus</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:28:49.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934602033</udiDi>
    <basicUdiDi>B-06945934602033</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-A08-M carton OPP Medplus 100pcs/carton</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:28:48.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934602026</udiDi>
    <basicUdiDi>B-06945934602026</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-A04-L single bag OPP Medplus</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:28:47.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934602019</udiDi>
    <basicUdiDi>B-06945934602019</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-A04-M single bag OPP Medplus</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:28:46.601Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934602002</udiDi>
    <basicUdiDi>B-06945934602002</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-L single bag OPP Medplus</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:28:40.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934601999</udiDi>
    <basicUdiDi>B-06945934601999</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 single bag OPP Medplus</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:28:39.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934601982</udiDi>
    <basicUdiDi>B-06945934601982</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 single bag OPP Medplus</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:28:37.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934601944</udiDi>
    <basicUdiDi>B-06945934601944</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-A08-S single bag OPP Medplus</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:28:37.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934601937</udiDi>
    <basicUdiDi>B-06945934601937</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-A04-S single bag OPP Medplus</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:28:29.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934601920</udiDi>
    <basicUdiDi>B-06945934601920</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>HK-B03-W single bag</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:28:28.366Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934601913</udiDi>
    <basicUdiDi>B-06945934601913</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 single bag OPP Medplus</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:28:27.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934601906</udiDi>
    <basicUdiDi>B-06945934601906</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 OPP Medplus</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:28:25.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934601890</udiDi>
    <basicUdiDi>B-06945934601890</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>HK-B03-T</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:28:20.320Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934601524</udiDi>
    <basicUdiDi>B-06945934601524</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</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:28:17.510Z</lastUpdated>
  </row>
</eudamedExport>