<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06936020141000</udiDi>
    <basicUdiDi>6936020120BRB</basicUdiDi>
    <tradeName>Pepino®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCG10-PP-01-2t</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-19T04:56:26.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936020141017</udiDi>
    <basicUdiDi>6936020120BRB</basicUdiDi>
    <tradeName>Pepino®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCG10-PP-03-1t</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-19T04:56:26.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996003926</udiDi>
    <basicUdiDi>69509960FAHCG-402a-DRAR</basicUdiDi>
    <tradeName>β-hCG Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName>β-hCG Quantitative Test Kit (Time-Resolved FIA)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FAHCG-402a-DR10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:49:08.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996003933</udiDi>
    <basicUdiDi>69509960FAHCG-402a-DRAR</basicUdiDi>
    <tradeName>β-hCG Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FAHCG-402a-DR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:47:21.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939663910712</udiDi>
    <basicUdiDi>B-06939663910712</basicUdiDi>
    <tradeName>hCG One Step Pregnancy Test</tradeName>
    <deviceName>hCG ONE STEP PREGNANCY TEST</deviceName>
    <manufacturerName>Sejoy Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008447</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>hCG-103a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:07:49.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936983100519</udiDi>
    <basicUdiDi>B-06936983100519</basicUdiDi>
    <tradeName>Pregnancy (hCG) Enhanced Sensitivity Rapid Test</tradeName>
    <deviceName>Pregnancy (hCG) Enhanced Sensitivity Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-U103H</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:07:30.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056668200974</udiDi>
    <basicUdiDi>B-05056668200974</basicUdiDi>
    <tradeName>Pregnancy (hCG) Enhanced Sensitivity Rapid Test</tradeName>
    <deviceName>Pregnancy (hCG) Enhanced Sensitivity Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-U103H</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:52:54.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052742680424</udiDi>
    <basicUdiDi>69360201208J</basicUdiDi>
    <tradeName>Validcheck®</tradeName>
    <deviceName>Human Chorionic Gonadotropin (HCG) Pregnancy Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCG-VC-03-1t</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:30:40.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FHC-U40294</udiDi>
    <basicUdiDi>B-FHC-U40294</basicUdiDi>
    <tradeName>hCG Pregnancy Enhanced Sensitivity Rapid Test Cassette</tradeName>
    <deviceName>hCG Pregnancy Enhanced Sensitivity Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-U402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:01:34.145Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FHC-U2118T</udiDi>
    <basicUdiDi>B-FHC-U2118T</basicUdiDi>
    <tradeName>hCG Pregnancy Enhanced Sensitivity Rapid Test Dipstick</tradeName>
    <deviceName>hCG Pregnancy Enhanced Sensitivity Rapid Test Dipstick</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-U211</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:01:30.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FHC-U2028S</udiDi>
    <basicUdiDi>B-FHC-U2028S</basicUdiDi>
    <tradeName>hCG Pregnancy Enhanced Sensitivity Rapid Test Cassette</tradeName>
    <deviceName>hCG Pregnancy Enhanced Sensitivity Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-U202</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:01:29.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FHC-U2018Q</udiDi>
    <basicUdiDi>B-FHC-U2018Q</basicUdiDi>
    <tradeName>hCG Pregnancy Enhanced Sensitivity Rapid Test Dipstick</tradeName>
    <deviceName>hCG Pregnancy Enhanced Sensitivity Rapid Test Dipstick</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-U201</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:01:27.653Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FHC-U1118N</udiDi>
    <basicUdiDi>B-FHC-U1118N</basicUdiDi>
    <tradeName>hCG Pregnancy Enhanced Sensitivity Rapid Test Dipstick</tradeName>
    <deviceName>hCG Pregnancy Enhanced Sensitivity Rapid Test Dipstick</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-U111</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:01:26.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FHC-U1038P</udiDi>
    <basicUdiDi>B-FHC-U1038P</basicUdiDi>
    <tradeName>hCG Pregnancy Enhanced Sensitivity Rapid Test Midstream</tradeName>
    <deviceName>hCG Pregnancy Enhanced Sensitivity Rapid Test Midstream</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-U103</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:01:25.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FHC-U1018K</udiDi>
    <basicUdiDi>B-FHC-U1018K</basicUdiDi>
    <tradeName>hCG Pregnancy  Enhanced Sensitivity Rapid Test Dipstick</tradeName>
    <deviceName>hCG Pregnancy  Enhanced Sensitivity Rapid Test Dipstick</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-U101</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:01:24.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FHC-F103HR4</udiDi>
    <basicUdiDi>B-FHC-F103HR4</basicUdiDi>
    <tradeName>HCG Pregnancy Rapid Test Midstream</tradeName>
    <deviceName>HCG Pregnancy Rapid Test Midstream</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-F103H</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:01:22.016Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FHC-402LG</udiDi>
    <basicUdiDi>B-FHC-402LG</basicUdiDi>
    <tradeName>hCG Pregnancy  Rapid Test Cassette</tradeName>
    <deviceName>hCG Pregnancy  Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:01:17.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FHC-F1035E</udiDi>
    <basicUdiDi>B-FHC-F1035E</basicUdiDi>
    <tradeName>HCG Pregnancy Rapid Test Midstream</tradeName>
    <deviceName>HCG Pregnancy Rapid Test Midstream</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-F103</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:01:16.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FHC-211L7</udiDi>
    <basicUdiDi>B-FHC-211L7</basicUdiDi>
    <tradeName>hCG Pregnancy  Rapid Test Dipstick</tradeName>
    <deviceName>hCG Pregnancy  Rapid Test Dipstick</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-211</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:01:16.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FHC-111L2</udiDi>
    <basicUdiDi>B-FHC-111L2</basicUdiDi>
    <tradeName>hCG Pregnancy  Rapid Test Dipstick</tradeName>
    <deviceName>hCG Pregnancy  Rapid Test Dipstick</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHC-111</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:01:12.001Z</lastUpdated>
  </row>
</eudamedExport>