<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06947462400815</udiDi>
    <basicUdiDi>6947462411111117LS</basicUdiDi>
    <tradeName>Disposable Vaginal speculum</tradeName>
    <deviceName>Disposable Vaginal Speculum</deviceName>
    <manufacturerName>Zhejiang Gongdong Medical Technology Co., Ltd.,</manufacturerName>
    <manufacturerSrn>CN-MF-000005694</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>P1001-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:29:05.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934606536</udiDi>
    <basicUdiDi>B-06945934606536</basicUdiDi>
    <tradeName>vaginal speculum</tradeName>
    <deviceName>vaginal speculum, side screw, S</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 side screw</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:31:45.191Z</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>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>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>
  <row>
    <udiDi>06945934604839</udiDi>
    <basicUdiDi>B-06945934604839</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 OPP INVISIO</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:30:44.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934603634</udiDi>
    <basicUdiDi>B-06945934603634</basicUdiDi>
    <tradeName>Vaginal speculum, French type, Size L, Single bag</tradeName>
    <deviceName>Vaginal speculum, French 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-A06-L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:30:36.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934603627</udiDi>
    <basicUdiDi>B-06945934603627</basicUdiDi>
    <tradeName>Vaginal speculum, French type, Size M, Single bag</tradeName>
    <deviceName>Vaginal speculum, French 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-A06-M</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:30:35.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934603610</udiDi>
    <basicUdiDi>B-06945934603610</basicUdiDi>
    <tradeName>vaginal speculum, french type, single bag</tradeName>
    <deviceName>Vaginal speculum, French 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-A06-S</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:30:34.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934603603</udiDi>
    <basicUdiDi>B-06945934603603</basicUdiDi>
    <tradeName>vaginal speculum</tradeName>
    <deviceName>Vaginal speculum, French type, Size XS, 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-A06-XS</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:30:33.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934603368</udiDi>
    <basicUdiDi>B-06945934603368</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 GLSMED</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:30:17.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934603351</udiDi>
    <basicUdiDi>B-06945934603351</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 GLSMED</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:30:16.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934603344</udiDi>
    <basicUdiDi>B-06945934603344</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 GLSMED</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:30:15.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945934603214</udiDi>
    <basicUdiDi>B-06945934603214</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 Blister Medplus</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-27T20:30:05.544Z</lastUpdated>
  </row>
</eudamedExport>