<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-TESTO-C06aW2</udiDi>
    <basicUdiDi>B-TESTO-C06aW2</basicUdiDi>
    <tradeName>Testo Test Kit FIA</tradeName>
    <deviceName>Testo Test Kit FIA</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TESTO-C06a</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:58:25.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SP10-K02aVR</udiDi>
    <basicUdiDi>B-SP10-K02aVR</basicUdiDi>
    <tradeName>SP-10 Rapid Test</tradeName>
    <deviceName>SP-10 Rapid Test</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP10-K02a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:56:31.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111724145</udiDi>
    <basicUdiDi>88001117IPBA01IA33W6</basicUdiDi>
    <tradeName>STANDARD™ i LH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16LH10F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:45:44.178Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111724152</udiDi>
    <basicUdiDi>88001117IPBA01IA33W6</basicUdiDi>
    <tradeName>STANDARD™ i LH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16LH10Q</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:45:43.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RPOG-C06aL4</udiDi>
    <basicUdiDi>B-RPOG-C06aL4</basicUdiDi>
    <tradeName>RPOG Test Kit FIA</tradeName>
    <deviceName>RPOG Test Kit FIA</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RPOG-C06a</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:28:36.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RH-SP10XW</udiDi>
    <basicUdiDi>B-RH-SP10XW</basicUdiDi>
    <tradeName>DAVID, easy@Home</tradeName>
    <deviceName>Male Fertility Sperm Test for Self-testing</deviceName>
    <manufacturerName>Equinox Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018901</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RH-SP10-S, RH-SP10-C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:27:34.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RH-LHZA</udiDi>
    <basicUdiDi>B-RH-LHZA</basicUdiDi>
    <tradeName>DAVID, Family Care Med+, Z1 Pharma</tradeName>
    <deviceName>One Step Ovulation Urine Tests for Self-testing</deviceName>
    <manufacturerName>Equinox Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018901</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LH-MS1, LH-MS2, LH-LS, RH-sLH</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:27:31.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RH-HCGE4</udiDi>
    <basicUdiDi>B-RH-HCGE4</basicUdiDi>
    <tradeName>DAVID, Family Care Med+, Z1 Pharma , KTX7</tradeName>
    <deviceName>One Step Pregnancy Urine Test for Self-testing</deviceName>
    <manufacturerName>Equinox Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018901</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>HCG-HS, HCG-MS, HCG-MS1, HCG-LS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:27:31.087Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RH-FSHFC</udiDi>
    <basicUdiDi>B-RH-FSHFC</basicUdiDi>
    <tradeName>DAVID</tradeName>
    <deviceName>One Step FSH Urine Test for Self-testing</deviceName>
    <manufacturerName>Equinox Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018901</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160301</emdnCode>
    <emdnDescription>FSH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RH-FSH-S, RH-FSH-C, RH-FSH-B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:27:29.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PRL-D06aNS</udiDi>
    <basicUdiDi>B-PRL-D06aNS</basicUdiDi>
    <tradeName>PRL Test Kit FIA</tradeName>
    <deviceName>PRL Test Kit FIA</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRL-D06a</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T14:12:15.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PMS-150Z7</udiDi>
    <basicUdiDi>B-PMS-150Z7</basicUdiDi>
    <tradeName>Premom Pregnancy Test</tradeName>
    <deviceName>Premom Pregnancy Test</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 Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMS-150</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T14:02:15.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PMS-120YW</udiDi>
    <basicUdiDi>B-PMS-120YW</basicUdiDi>
    <tradeName>Premom Pregnancy Test</tradeName>
    <deviceName>Premom Pregnancy Test</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 Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMS-120</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T14:02:14.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-LH-D06aPR</udiDi>
    <basicUdiDi>B-LH-D06aPR</basicUdiDi>
    <tradeName>LH Test Kit FIA</tradeName>
    <deviceName>LH Test Kit FIA</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LH-D06a</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:49:20.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HCG-D06a82</udiDi>
    <basicUdiDi>B-HCG-D06a82</basicUdiDi>
    <tradeName>β-HCG Test Kit FIA</tradeName>
    <deviceName>β-HCG Test Kit FIA</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>β-HCG-D06a</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:53:13.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD174XT</udiDi>
    <basicUdiDi>B-GKPD174XT</basicUdiDi>
    <tradeName>LH Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>LH Detection Kit (Immunofluorescence Chromatography)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD174</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:39:27.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD173XR</udiDi>
    <basicUdiDi>B-GKPD173XR</basicUdiDi>
    <tradeName>FSH Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>FSH Detection Kit (Immunofluorescence Chromatography)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160301</emdnCode>
    <emdnDescription>FSH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD173</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:39:23.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD172XP</udiDi>
    <basicUdiDi>B-GKPD172XP</basicUdiDi>
    <tradeName>FSH / LH Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>FSH / LH Detection Kit (Immunofluorescence Chromatography)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD172</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:39:22.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD143XG</udiDi>
    <basicUdiDi>B-GKPD143XG</basicUdiDi>
    <tradeName>FSH Rapid Test Kit</tradeName>
    <deviceName>FSH Rapid Test Kit</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160301</emdnCode>
    <emdnDescription>FSH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD143</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:38:23.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GALH-103b-7TG9</udiDi>
    <basicUdiDi>B-GALH-103b-7TG9</basicUdiDi>
    <tradeName>LH Ovulation Rapid Test</tradeName>
    <deviceName>LH Ovulation Rapid Test</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 Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GALH-103b-7T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:14:46.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GALH-103b-5THGNX</udiDi>
    <basicUdiDi>B-GALH-103b-5THGNX</basicUdiDi>
    <tradeName>LH Ovulation Rapid Test</tradeName>
    <deviceName>LH Ovulation Rapid Test</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GALH-103b-5T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:14:45.549Z</lastUpdated>
  </row>
</eudamedExport>