<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-GAHCG-103a-1THGWP</udiDi>
    <basicUdiDi>B-GAHCG-103a-1THGWP</basicUdiDi>
    <tradeName>HCG Pregnancy Rapid Test</tradeName>
    <deviceName>HCG Pregnancy 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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAHCG-103a-1T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:04:22.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GAHCG-102nR7</udiDi>
    <basicUdiDi>B-GAHCG-102nR7</basicUdiDi>
    <tradeName>One Step Pregnancy Test Cassette (Urine)</tradeName>
    <deviceName>One Step Pregnancy Test Cassette (Urine)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAHCG-102n</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:04:20.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GAHCG-102nHGMU</udiDi>
    <basicUdiDi>B-GAHCG-102nHGMU</basicUdiDi>
    <tradeName>One Step Pregnancy Test Cassette (Urine)</tradeName>
    <deviceName>One Step Pregnancy Test Cassette (Urine)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAHCG-102n</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:04:18.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GAHCG-102mR5</udiDi>
    <basicUdiDi>B-GAHCG-102mR5</basicUdiDi>
    <tradeName>One Step Pregnancy Test Cassette (Urine)</tradeName>
    <deviceName>One Step Pregnancy Test Cassette (Urine)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAHCG-102m</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:04:16.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GAHCG-102mHGMP</udiDi>
    <basicUdiDi>B-GAHCG-102mHGMP</basicUdiDi>
    <tradeName>One Step Pregnancy Test Cassette (Urine)</tradeName>
    <deviceName>One Step Pregnancy Test Cassette (Urine)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAHCG-102m</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:04:15.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GAHCG-102dQK</udiDi>
    <basicUdiDi>B-GAHCG-102dQK</basicUdiDi>
    <tradeName>One Step Pregnancy Test Cassette (Urine)</tradeName>
    <deviceName>One Step Pregnancy Test Cassette (Urine)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAHCG-102d</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:04:14.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GAHCG-102d-5THGY9</udiDi>
    <basicUdiDi>B-GAHCG-102d-5THGY9</basicUdiDi>
    <tradeName>HCG Pregnancy Rapid Test</tradeName>
    <deviceName>HCG Pregnancy 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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAHCG-102d-5T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:04:11.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GAHCG-102d-2TKS</udiDi>
    <basicUdiDi>B-GAHCG-102d-2TKS</basicUdiDi>
    <tradeName>HCG Pregnancy Rapid Test</tradeName>
    <deviceName>HCG Pregnancy 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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAHCG-102d-2T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:04:10.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GAHCG-102dHGLA</udiDi>
    <basicUdiDi>B-GAHCG-102dHGLA</basicUdiDi>
    <tradeName>One Step Pregnancy Test Cassette (Urine)</tradeName>
    <deviceName>One Step Pregnancy Test Cassette (Urine)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAHCG-102d</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:04:09.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GAHCG-102d-5TL3</udiDi>
    <basicUdiDi>B-GAHCG-102d-5TL3</basicUdiDi>
    <tradeName>HCG Pregnancy Rapid Test</tradeName>
    <deviceName>HCG Pregnancy 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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAHCG-102d-5T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:04:07.626Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GAHCG-102d-2THGXL</udiDi>
    <basicUdiDi>B-GAHCG-102d-2THGXL</basicUdiDi>
    <tradeName>HCG Pregnancy Rapid Test</tradeName>
    <deviceName>HCG Pregnancy 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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAHCG-102d-2T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:03:51.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GAHCG-102d-25TQ9</udiDi>
    <basicUdiDi>B-GAHCG-102d-25TQ9</basicUdiDi>
    <tradeName>HCG Pregnancy Rapid Test</tradeName>
    <deviceName>HCG Pregnancy 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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAHCG-102d-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:03:51.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GAHCG-102d-1TKP</udiDi>
    <basicUdiDi>B-GAHCG-102d-1TKP</basicUdiDi>
    <tradeName>HCG Pregnancy Rapid Test</tradeName>
    <deviceName>HCG Pregnancy 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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAHCG-102d-1T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:03:49.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GAHCG-102d-1THGXD</udiDi>
    <basicUdiDi>B-GAHCG-102d-1THGXD</basicUdiDi>
    <tradeName>HCG Pregnancy Rapid Test</tradeName>
    <deviceName>HCG Pregnancy 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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAHCG-102d-1T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:03:49.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GAHCG-102bQF</udiDi>
    <basicUdiDi>B-GAHCG-102bQF</basicUdiDi>
    <tradeName>One Step Pregnancy Test Cassette (Urine)</tradeName>
    <deviceName>One Step Pregnancy Test Cassette (Urine)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAHCG-102b</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:03:44.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GAHCG-102bHGKY</udiDi>
    <basicUdiDi>B-GAHCG-102bHGKY</basicUdiDi>
    <tradeName>One Step Pregnancy Test Cassette (Urine)</tradeName>
    <deviceName>One Step Pregnancy Test Cassette (Urine)</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAHCG-102b</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:03:44.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GAHCG-102b-5TKM</udiDi>
    <basicUdiDi>B-GAHCG-102b-5TKM</basicUdiDi>
    <tradeName>HCG Pregnancy Rapid Test</tradeName>
    <deviceName>HCG Pregnancy 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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAHCG-102b-5T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:03:43.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GAHCG-102b-5THGXF</udiDi>
    <basicUdiDi>B-GAHCG-102b-5THGXF</basicUdiDi>
    <tradeName>HCG Pregnancy Rapid Test</tradeName>
    <deviceName>HCG Pregnancy 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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAHCG-102b-5T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:03:42.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GAHCG-102b-2TKC</udiDi>
    <basicUdiDi>B-GAHCG-102b-2TKC</basicUdiDi>
    <tradeName>HCG Pregnancy Rapid Test</tradeName>
    <deviceName>HCG Pregnancy 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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAHCG-102b-2T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:03:38.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GAHCG-102b-2THGWS</udiDi>
    <basicUdiDi>B-GAHCG-102b-2THGWS</basicUdiDi>
    <tradeName>HCG Pregnancy Rapid Test</tradeName>
    <deviceName>HCG Pregnancy 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>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAHCG-102b-2T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:03:37.724Z</lastUpdated>
  </row>
</eudamedExport>