<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-GCHSV(IgG)-402aHGC5</udiDi>
    <basicUdiDi>B-GCHSV(IgG)-402aHGC5</basicUdiDi>
    <tradeName>HSV IgG Rapid Test Cassette (Whole blood/Serum/Plasma)</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCHSV(IgG)-402a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:38.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCHSV(IgM)-302aHGG2</udiDi>
    <basicUdiDi>B-GCHSV(IgM)-302aHGG2</basicUdiDi>
    <tradeName>HSV IgM Rapid Test Cassette (Serum/Plasma)</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCHSV(IgM)-302a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:38.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCHSV(IgM)-402aHGGF</udiDi>
    <basicUdiDi>B-GCHSV(IgM)-402aHGGF</basicUdiDi>
    <tradeName>HSV IgM Rapid Test Cassette (Whole blood/Serum/Plasma)</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCHSV(IgM)-402a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:38.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCHV(IgG/IgM)-402aHGXA</udiDi>
    <basicUdiDi>B-GCHV(IgG/IgM)-402aHGXA</basicUdiDi>
    <tradeName>Hantavirus IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCHV(IgG/IgM)-402a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:37.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCHV(IgM)-402aHGY5</udiDi>
    <basicUdiDi>B-GCHV(IgM)-402aHGY5</basicUdiDi>
    <tradeName>Hantavirus IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCHV(IgM)-402a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:37.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCKal-401aHGWJ</udiDi>
    <basicUdiDi>B-GCKal-401aHGWJ</basicUdiDi>
    <tradeName>Leishmania Ab Rapid Test Strip (Whole Blood/Serum/Plasma)</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCKal-401a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:37.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCKal-402aHGWR</udiDi>
    <basicUdiDi>B-GCKal-402aHGWR</basicUdiDi>
    <tradeName>Leishmania Ab Rapid Test Cassette (Whole Blood/Serum/Plasma)</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCKal-402a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:37.606Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCKal-T402aHGQK</udiDi>
    <basicUdiDi>B-GCKal-T402aHGQK</basicUdiDi>
    <tradeName>Leishmania IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCKal-T402a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:37.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCLEP(IgG/IgM)-402aHG8L</udiDi>
    <basicUdiDi>B-GCLEP(IgG/IgM)-402aHG8L</basicUdiDi>
    <tradeName>Leptospira IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCLEP(IgG/IgM)-402a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:37.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMAL(pan)-402aHG2H</udiDi>
    <basicUdiDi>B-GCMAL(pan)-402aHG2H</basicUdiDi>
    <tradeName>Malaria Pan Ag Rapid Test Cassette (Whole Blood)</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCMAL(pan)-402a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:37.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMAL(Pf)-402aHGKG</udiDi>
    <basicUdiDi>B-GCMAL(Pf)-402aHGKG</basicUdiDi>
    <tradeName>Malaria Pf Ag Rapid Test Cassette (Whole Blood)</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCMAL(Pf)-402a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:37.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMAL(pf/pan)-402aHGAD</udiDi>
    <basicUdiDi>B-GCMAL(pf/pan)-402aHGAD</basicUdiDi>
    <tradeName>Malaria P.f./Pan Ag Rapid Test Cassette (Whole Blood)</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCMAL(pf/pan)-402a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:37.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMAL(pf/pv)-402aHGG2</udiDi>
    <basicUdiDi>B-GCMAL(pf/pv)-402aHGG2</basicUdiDi>
    <tradeName>Malaria P.f./P.v. Ag Rapid Test Cassette (Whole Blood)</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCMAL(pf/pv)-402a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:37.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMAL(pf/pvAb)-302aHG79</udiDi>
    <basicUdiDi>B-GCMAL(pf/pvAb)-302aHG79</basicUdiDi>
    <tradeName>Malaria Pf/Pv Ab Rapid Test Cassette (Serum/Plasma)</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCMAL(pf/pv Ab)-302a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:36.999Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMAL(pf/pvAb)-402aHG7N</udiDi>
    <basicUdiDi>B-GCMAL(pf/pvAb)-402aHG7N</basicUdiDi>
    <tradeName>Malaria Pf/Pv Ab Rapid Test Cassette (whole blood/serum/plasma)</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCMAL(pf/pv Ab)-402a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:36.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMKP-402aHG6P</udiDi>
    <basicUdiDi>B-GCMKP-402aHG6P</basicUdiDi>
    <tradeName>Monkeypox IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCMKP-402a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:36.820Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMKP-502bHG79</udiDi>
    <basicUdiDi>B-GCMKP-502bHG79</basicUdiDi>
    <tradeName>Monkeypox Ag Rapid Test Cassette (Swab)</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCMKP-502b</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:36.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMON-325aHG9B</udiDi>
    <basicUdiDi>B-GCMON-325aHG9B</basicUdiDi>
    <tradeName>Mononucleosis IgG/lgM Rapid Test Cassette(Serum/Plasma)</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCMON-325a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:36.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMON-402aHG8D</udiDi>
    <basicUdiDi>B-GCMON-402aHG8D</basicUdiDi>
    <tradeName>Mononucleosis Rapid Test Cassette (Whole Blood/Serum/Plasma)</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCMON-402a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:36.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMON-425aHG9Q</udiDi>
    <basicUdiDi>B-GCMON-425aHG9Q</basicUdiDi>
    <tradeName>Mononucleosis IgG/IgM Rapid Test Cassette (Whole blood/Serum/Plasma)</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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCMON-425a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:36.463Z</lastUpdated>
  </row>
</eudamedExport>