<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-GALH-103b-5TG3</udiDi>
    <basicUdiDi>B-GALH-103b-5TG3</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-5T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:14:41.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GALH-103b-2THGNA</udiDi>
    <basicUdiDi>B-GALH-103b-2THGNA</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-2T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:14:40.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GALH-103b-2TFS</udiDi>
    <basicUdiDi>B-GALH-103b-2TFS</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-2T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:14:39.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GALH-103b-25TJ3</udiDi>
    <basicUdiDi>B-GALH-103b-25TJ3</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-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:14:39.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GALH-103b-25THGTR</udiDi>
    <basicUdiDi>B-GALH-103b-25THGTR</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-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:14:35.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GALH-103b-1THGN3</udiDi>
    <basicUdiDi>B-GALH-103b-1THGN3</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-1T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:14:34.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GALH-103b-1TFP</udiDi>
    <basicUdiDi>B-GALH-103b-1TFP</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-1T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:14:33.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GALH-103b-10THGSB</udiDi>
    <basicUdiDi>B-GALH-103b-10THGSB</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-10T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:14:33.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GALH-103b-10THF</udiDi>
    <basicUdiDi>B-GALH-103b-10THF</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-10T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:14:28.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GALH-103a-7TG2</udiDi>
    <basicUdiDi>B-GALH-103a-7TG2</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-103a-7T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:14:27.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GALH-103a-5THGNJ</udiDi>
    <basicUdiDi>B-GALH-103a-5THGNJ</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-103a-5T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:14:27.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GALH-103a-5TFU</udiDi>
    <basicUdiDi>B-GALH-103a-5TFU</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-103a-5T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:14:26.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GALH-103a-2THGMV</udiDi>
    <basicUdiDi>B-GALH-103a-2THGMV</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-103a-2T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:14:22.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GALH-103a-2TFK</udiDi>
    <basicUdiDi>B-GALH-103a-2TFK</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-103a-2T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:14:21.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GALH-103a-25THQ</udiDi>
    <basicUdiDi>B-GALH-103a-25THQ</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-103a-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:14:20.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GALH-103a-25THGT8</udiDi>
    <basicUdiDi>B-GALH-103a-25THGT8</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-103a-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:14:19.936Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GALH-103a-1THGMN</udiDi>
    <basicUdiDi>B-GALH-103a-1THGMN</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-103a-1T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:14:15.942Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GALH-103a-1TFG</udiDi>
    <basicUdiDi>B-GALH-103a-1TFG</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-103a-1T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:14:15.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GALH-103a-10THGRS</udiDi>
    <basicUdiDi>B-GALH-103a-10THGRS</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-103a-10T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:14:14.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GALH-103a-10TH4</udiDi>
    <basicUdiDi>B-GALH-103a-10TH4</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-103a-10T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:14:09.581Z</lastUpdated>
  </row>
</eudamedExport>