<?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-FKCOR-PN20F2</udiDi>
    <basicUdiDi>B-FKCOR-PN20F2</basicUdiDi>
    <tradeName>Cortisol Control</tradeName>
    <deviceName>Cortisol 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>W0102152008</emdnCode>
    <emdnDescription>CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FKCOR-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:34:09.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FKCOR-PN20HGNH</udiDi>
    <basicUdiDi>B-FKCOR-PN20HGNH</basicUdiDi>
    <tradeName>Cortisol 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>W0102152008</emdnCode>
    <emdnDescription>CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FKCOR-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:34:07.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIVD-PN20HGCE</udiDi>
    <basicUdiDi>B-FIVD-PN20HGCE</basicUdiDi>
    <tradeName>25-OH-VD 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>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIVD-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:33:48.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIVD-PN20E5</udiDi>
    <basicUdiDi>B-FIVD-PN20E5</basicUdiDi>
    <tradeName>25-OH-VD Control</tradeName>
    <deviceName>25-OH-VD 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>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIVD-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:33:44.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIVB12-LP3ZR</udiDi>
    <basicUdiDi>B-FIVB12-LP3ZR</basicUdiDi>
    <tradeName>VB12 Control</tradeName>
    <deviceName>VB12 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>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIVB12-LP3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:33:41.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIVB12-LP3HG4E</udiDi>
    <basicUdiDi>B-FIVB12-LP3HG4E</basicUdiDi>
    <tradeName>VB12 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>W0102152006</emdnCode>
    <emdnDescription>ANAEMIA RELATED/VITAMIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIVB12-LP3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:33:37.717Z</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-FINGA-PN20HGEP</udiDi>
    <basicUdiDi>B-FINGA-PN20HGEP</basicUdiDi>
    <tradeName>NGAL 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>W0102152008</emdnCode>
    <emdnDescription>CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FINGA-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:33:22.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FINGA-PN208Y</udiDi>
    <basicUdiDi>B-FINGA-PN208Y</basicUdiDi>
    <tradeName>NGAL Control</tradeName>
    <deviceName>NGAL 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>W0102152008</emdnCode>
    <emdnDescription>CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FINGA-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:33:18.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIMG-PN20HG7Q</udiDi>
    <basicUdiDi>B-FIMG-PN20HG7Q</basicUdiDi>
    <tradeName>Beta2-MG 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>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIMG-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:33:16.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIMG-PN20AK</udiDi>
    <basicUdiDi>B-FIMG-PN20AK</basicUdiDi>
    <tradeName>Beta2-MG Control</tradeName>
    <deviceName>Beta2-MG 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>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIMG-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:33:12.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIMAU-PN20HGMC</udiDi>
    <basicUdiDi>B-FIMAU-PN20HGMC</basicUdiDi>
    <tradeName>MAU 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>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIMAU-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:29:18.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIMAU-PN20DB</udiDi>
    <basicUdiDi>B-FIMAU-PN20DB</basicUdiDi>
    <tradeName>MAU Control</tradeName>
    <deviceName>MAU 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>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIMAU-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:29:12.965Z</lastUpdated>
  </row>
</eudamedExport>