<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>26972903331216</udiDi>
    <basicUdiDi>B-26972903331216</basicUdiDi>
    <tradeName>26972903331216</tradeName>
    <deviceName>Disposable vaginal speculum</deviceName>
    <manufacturerName>Yuhuan City Shengbo Mould Manufacturing Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000036867</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SY002-M</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:14:55.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>26972903331155</udiDi>
    <basicUdiDi>B-26972903331155</basicUdiDi>
    <tradeName>26972903331155</tradeName>
    <deviceName>Disposable vaginal speculum</deviceName>
    <manufacturerName>Yuhuan City Shengbo Mould Manufacturing Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000036867</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SY001A-XL</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:14:54.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>26972903331209</udiDi>
    <basicUdiDi>B-26972903331209</basicUdiDi>
    <tradeName>26972903331209</tradeName>
    <deviceName>Disposable vaginal speculum</deviceName>
    <manufacturerName>Yuhuan City Shengbo Mould Manufacturing Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000036867</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SY0002-S</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:14:53.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>26972903331131</udiDi>
    <basicUdiDi>B-26972903331131</basicUdiDi>
    <tradeName>26972903331131</tradeName>
    <deviceName>Disposable vaginal speculum</deviceName>
    <manufacturerName>Yuhuan City Shengbo Mould Manufacturing Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000036867</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SY001A-M</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:14:50.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>26972903331148</udiDi>
    <basicUdiDi>B-26972903331148</basicUdiDi>
    <tradeName>26972903331148</tradeName>
    <deviceName>Disposable vaginal speculum</deviceName>
    <manufacturerName>Yuhuan City Shengbo Mould Manufacturing Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000036867</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SY001A-L</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:14:49.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>26972903331124</udiDi>
    <basicUdiDi>B-26972903331124</basicUdiDi>
    <tradeName>26972903331124</tradeName>
    <deviceName>Disposable vaginal speculum</deviceName>
    <manufacturerName>Yuhuan City Shengbo Mould Manufacturing Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000036867</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SY001A-S</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:14:35.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>26972903331117</udiDi>
    <basicUdiDi>B-26972903331117</basicUdiDi>
    <tradeName>26972903331117</tradeName>
    <deviceName>Disposable vaginal speculum</deviceName>
    <manufacturerName>Yuhuan City Shengbo Mould Manufacturing Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000036867</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SY001A-XS</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:14:33.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>26972903331100</udiDi>
    <basicUdiDi>B-26972903331100</basicUdiDi>
    <tradeName>26972903331100</tradeName>
    <deviceName>Disposable vaginal speculum</deviceName>
    <manufacturerName>Yuhuan City Shengbo Mould Manufacturing Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000036867</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SY001A-XXS</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:14:30.605Z</lastUpdated>
  </row>
  <row>
    <udiDi>26972903331049</udiDi>
    <basicUdiDi>B-26972903331049</basicUdiDi>
    <tradeName>26972903331049</tradeName>
    <deviceName>Disposable vaginal speculum</deviceName>
    <manufacturerName>Yuhuan City Shengbo Mould Manufacturing Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000036867</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SY001-L</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:14:29.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>26972903331032</udiDi>
    <basicUdiDi>B-26972903331032</basicUdiDi>
    <tradeName>26972903331032</tradeName>
    <deviceName>Disposable vaginal speculum</deviceName>
    <manufacturerName>Yuhuan City Shengbo Mould Manufacturing Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000036867</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SY001-M</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:14:29.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>26972903331025</udiDi>
    <basicUdiDi>B-26972903331025</basicUdiDi>
    <tradeName>26972903331025</tradeName>
    <deviceName>Disposable vaginal speculum</deviceName>
    <manufacturerName>Yuhuan City Shengbo Mould Manufacturing Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000036867</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:14:25.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>26972903331001</udiDi>
    <basicUdiDi>B-26972903331001</basicUdiDi>
    <tradeName>26972903331001</tradeName>
    <deviceName>Disposable vaginal speculum</deviceName>
    <manufacturerName>Yuhuan City Shengbo Mould Manufacturing Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000036867</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SY001-XXS</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:14:24.203Z</lastUpdated>
  </row>
  <row>
    <udiDi>26945934602006</udiDi>
    <basicUdiDi>B-26945934602006</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 carton OPP Medplus 150pcs/carton</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:47:30.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>26945934601993</udiDi>
    <basicUdiDi>B-26945934601993</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 carton OPP Medplus 150pcs/carton</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:47:29.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>26945934601986</udiDi>
    <basicUdiDi>B-26945934601986</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 carton OPP Medplus 150pcs/carton</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:47:25.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>26945934601917</udiDi>
    <basicUdiDi>B-26945934601917</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 carton OPP Medplus 150pcs/carton</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:47:24.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>26945934601900</udiDi>
    <basicUdiDi>B-26945934601900</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 carton OPP Medplus 150pcs/carton</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:47:23.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>18964003896420</udiDi>
    <basicUdiDi>B-18964003896420</basicUdiDi>
    <tradeName>Wrangler Instruments</tradeName>
    <deviceName>Speculum, vaginal, Graves, 115 x 35 mm</deviceName>
    <manufacturerName>Wrangler Instruments</manufacturerName>
    <manufacturerSrn>PK-MF-000009409</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15-410-03UN</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:10:41.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>18964003896413</udiDi>
    <basicUdiDi>B-18964003896413</basicUdiDi>
    <tradeName>Wrangler Instruments</tradeName>
    <deviceName>Speculum, vaginal, Graves, 95 x 35 mm</deviceName>
    <manufacturerName>Wrangler Instruments</manufacturerName>
    <manufacturerSrn>PK-MF-000009409</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15-410-02UN</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:10:40.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>18964003896406</udiDi>
    <basicUdiDi>B-18964003896406</basicUdiDi>
    <tradeName>Wrangler Instruments</tradeName>
    <deviceName>Speculum, vaginal, Graves, 75 x 20 mm</deviceName>
    <manufacturerName>Wrangler Instruments</manufacturerName>
    <manufacturerSrn>PK-MF-000009409</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15-410-01UN</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:10:39.668Z</lastUpdated>
  </row>
</eudamedExport>