<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-FKPTH-PN20MC</udiDi>
    <basicUdiDi>B-FKPTH-PN20MC</basicUdiDi>
    <tradeName>PTH Control</tradeName>
    <deviceName>PTH Control</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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FKPTH-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:34:34.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FKPTH-PN20HGXX</udiDi>
    <basicUdiDi>B-FKPTH-PN20HGXX</basicUdiDi>
    <tradeName>PTH Control</tradeName>
    <deviceName></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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FKPTH-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:34:33.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FKFT4-PN20HGBL</udiDi>
    <basicUdiDi>B-FKFT4-PN20HGBL</basicUdiDi>
    <tradeName>fT4 Control</tradeName>
    <deviceName></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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FKFT4-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:34:28.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FKFT4-PN207P</udiDi>
    <basicUdiDi>B-FKFT4-PN207P</basicUdiDi>
    <tradeName>fT4 Control</tradeName>
    <deviceName>fT4 Control</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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FKFT4-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:34:27.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FKFT3-PN20HGAZ</udiDi>
    <basicUdiDi>B-FKFT3-PN20HGAZ</basicUdiDi>
    <tradeName>fT3 Control</tradeName>
    <deviceName></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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FKFT3-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:34:20.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FKFT3-PN207A</udiDi>
    <basicUdiDi>B-FKFT3-PN207A</basicUdiDi>
    <tradeName>fT3 Control</tradeName>
    <deviceName>fT3 Control</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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FKFT3-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:34:16.178Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FITSH-PN20MR</udiDi>
    <basicUdiDi>B-FITSH-PN20MR</basicUdiDi>
    <tradeName>TSH Control</tradeName>
    <deviceName>TSH Control</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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FITSH-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:33:35.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FITSH-PN20HGYW</udiDi>
    <basicUdiDi>B-FITSH-PN20HGYW</basicUdiDi>
    <tradeName>TSH Control</tradeName>
    <deviceName></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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FITSH-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:33:31.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FEPRL-PN20HL</udiDi>
    <basicUdiDi>B-FEPRL-PN20HL</basicUdiDi>
    <tradeName>PRL Control</tradeName>
    <deviceName>PRL Control</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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FEPRL-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:26:52.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FEPRL-PN20HGT3</udiDi>
    <basicUdiDi>B-FEPRL-PN20HGT3</basicUdiDi>
    <tradeName>PRL Control</tradeName>
    <deviceName></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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FEPRL-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:26:48.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FAPRO-PN20HGQY</udiDi>
    <basicUdiDi>B-FAPRO-PN20HGQY</basicUdiDi>
    <tradeName>PROG Control</tradeName>
    <deviceName></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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FAPRO-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:17:29.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FAPRO-PN20FX</udiDi>
    <basicUdiDi>B-FAPRO-PN20FX</basicUdiDi>
    <tradeName>PROG Control</tradeName>
    <deviceName>PROG Control</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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FAPRO-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:17:28.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FALH-PN20HGY9</udiDi>
    <basicUdiDi>B-FALH-PN20HGY9</basicUdiDi>
    <tradeName>LH Control</tradeName>
    <deviceName></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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FALH-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:17:17.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FALH-PN205P</udiDi>
    <basicUdiDi>B-FALH-PN205P</basicUdiDi>
    <tradeName>LH Control</tradeName>
    <deviceName>LH Control</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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FALH-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:17:17.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FAHCG-PN20XV</udiDi>
    <basicUdiDi>B-FAHCG-PN20XV</basicUdiDi>
    <tradeName>Beta-HCG Control</tradeName>
    <deviceName>Beta-HCG Control</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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FAHCG-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:17:11.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FAHCG-PN20HG27</udiDi>
    <basicUdiDi>B-FAHCG-PN20HG27</basicUdiDi>
    <tradeName>Beta-HCG Control</tradeName>
    <deviceName></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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FAHCG-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:17:08.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FAFSH-PN20HGCG</udiDi>
    <basicUdiDi>B-FAFSH-PN20HGCG</basicUdiDi>
    <tradeName>FSH Control</tradeName>
    <deviceName></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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FAFSH-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:16:53.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FAFSH-PN207P</udiDi>
    <basicUdiDi>B-FAFSH-PN207P</basicUdiDi>
    <tradeName>FSH Control</tradeName>
    <deviceName>FSH Control</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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FAFSH-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:16:51.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FAE2-PN20RC</udiDi>
    <basicUdiDi>B-FAE2-PN20RC</basicUdiDi>
    <tradeName>E2 Control</tradeName>
    <deviceName>E2 Control</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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FAE2-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:16:46.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FAE2-PN20HGER</udiDi>
    <basicUdiDi>B-FAE2-PN20HGER</basicUdiDi>
    <tradeName>E2 Control</tradeName>
    <deviceName></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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FAE2-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:16:43.330Z</lastUpdated>
  </row>
</eudamedExport>