<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-FDPI-PN209Z</udiDi>
    <basicUdiDi>B-FDPI-PN209Z</basicUdiDi>
    <tradeName>PCT/IL-6 Control</tradeName>
    <deviceName>PCT/IL-6 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>FDPI-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:22:25.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FDPCT-PN20HGL3</udiDi>
    <basicUdiDi>B-FDPCT-PN20HGL3</basicUdiDi>
    <tradeName>PCT 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>FDPCT-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:22:24.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FDPCT-PN20C6</udiDi>
    <basicUdiDi>B-FDPCT-PN20C6</basicUdiDi>
    <tradeName>PCT Control</tradeName>
    <deviceName>PCT 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>FDPCT-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:22:20.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FDPC-LP3HH</udiDi>
    <basicUdiDi>B-FDPC-LP3HH</basicUdiDi>
    <tradeName>PCT/CRP Control</tradeName>
    <deviceName>PCT/CRP 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>W01021521</emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDPC-LP3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:22:13.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FDPC-LP3HG6B</udiDi>
    <basicUdiDi>B-FDPC-LP3HG6B</basicUdiDi>
    <tradeName>PCT/CRP 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>W01021521</emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDPC-LP3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:22:12.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FDMYO-PN20L2</udiDi>
    <basicUdiDi>B-FDMYO-PN20L2</basicUdiDi>
    <tradeName>Myo Control</tradeName>
    <deviceName>Myo 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>W0102152004</emdnCode>
    <emdnDescription>CARDIAC MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDMYO-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:22:11.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FDMYO-PN20HGW7</udiDi>
    <basicUdiDi>B-FDMYO-PN20HGW7</basicUdiDi>
    <tradeName>Myo 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>W0102152004</emdnCode>
    <emdnDescription>CARDIAC MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDMYO-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:22:07.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FDINF-LP3HG9J</udiDi>
    <basicUdiDi>B-FDINF-LP3HG9J</basicUdiDi>
    <tradeName>Inflammatory Markers 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>W01021521</emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDINF-LP3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:22:05.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FDINF-LP3BQ</udiDi>
    <basicUdiDi>B-FDINF-LP3BQ</basicUdiDi>
    <tradeName>Inflammatory Markers Control</tradeName>
    <deviceName>Inflammatory Markers 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>W01021521</emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDINF-LP3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:20:33.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FDIL6-PN20YW</udiDi>
    <basicUdiDi>B-FDIL6-PN20YW</basicUdiDi>
    <tradeName>IL-6 Control</tradeName>
    <deviceName>IL-6 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>FDIL6-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:20:32.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FDIL6-PN20HG2Y</udiDi>
    <basicUdiDi>B-FDIL6-PN20HG2Y</basicUdiDi>
    <tradeName>IL-6 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>FDIL6-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:20:31.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FDDCB-PN20VM</udiDi>
    <basicUdiDi>B-FDDCB-PN20VM</basicUdiDi>
    <tradeName>D-Dimer/ cTnI/ NT-proBNP Control</tradeName>
    <deviceName>D-Dimer/ cTnI/ NT-proBNP 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>W01021521</emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDDCB-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:20:18.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FDDCB-PN20HGWE</udiDi>
    <basicUdiDi>B-FDDCB-PN20HGWE</basicUdiDi>
    <tradeName>D-Dimer/ cTnI/ NT-proBNP 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>W01021521</emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDDCB-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:20:14.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FDCT-PN20HG3Q</udiDi>
    <basicUdiDi>B-FDCT-PN20HG3Q</basicUdiDi>
    <tradeName>CT 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>FDCT-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:20:13.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FDCT-PN207K</udiDi>
    <basicUdiDi>B-FDCT-PN207K</basicUdiDi>
    <tradeName>CT Control</tradeName>
    <deviceName>CT 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>FDCT-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:20:12.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FDCS-PN20HG35</udiDi>
    <basicUdiDi>B-FDCS-PN20HG35</basicUdiDi>
    <tradeName>CRP/SAA 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>W01021521</emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDCS-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:19:55.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FDCS-PN2076</udiDi>
    <basicUdiDi>B-FDCS-PN2076</basicUdiDi>
    <tradeName>CRP/SAA Control</tradeName>
    <deviceName>CRP/SAA 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>W01021521</emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDCS-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:19:51.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FDCKM-PN20HG9V</udiDi>
    <basicUdiDi>B-FDCKM-PN20HG9V</basicUdiDi>
    <tradeName>CK-MB 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>W0102152004</emdnCode>
    <emdnDescription>CARDIAC MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDCKM-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:19:50.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FDCKM-PN205U</udiDi>
    <basicUdiDi>B-FDCKM-PN205U</basicUdiDi>
    <tradeName>CK-MB Control</tradeName>
    <deviceName>CK-MB 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>W0102152004</emdnCode>
    <emdnDescription>CARDIAC MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDCKM-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:19:50.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FDCAR-PN20HG5N</udiDi>
    <basicUdiDi>B-FDCAR-PN20HG5N</basicUdiDi>
    <tradeName>cTnl/ Myo/ CK-MB 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>W01021521</emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDCAR-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:19:43.034Z</lastUpdated>
  </row>
</eudamedExport>