<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-GCCHK-402aHSR6</udiDi>
    <basicUdiDi>B-GCCHK-402aHSR6</basicUdiDi>
    <tradeName>One Step Chikungunya Ag Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HEALSTONE Biotech Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000057743</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>GCCHK-402a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:56:38.857Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCr(Ag)-402aHSEF</udiDi>
    <basicUdiDi>B-GCCr(Ag)-402aHSEF</basicUdiDi>
    <tradeName>Cryptococcal Ag Rapid Test Cassette (Whole Blood/Serum/Plasma/Cerebral Spinal Fluid)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HEALSTONE Biotech Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000057743</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>GCCr(Ag)-402a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:56:36.862Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCGON-502bHS49</udiDi>
    <basicUdiDi>B-GCGON-502bHS49</basicUdiDi>
    <tradeName>Gonorrhea Rapid Test Cassette (Swab)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HEALSTONE Biotech Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000057743</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>GCGON-502b</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:56:35.809Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCHPV-502aHSAG</udiDi>
    <basicUdiDi>B-GCHPV-502aHSAG</basicUdiDi>
    <tradeName>Human Papillomavirus E7 Protein Rapid Test Cassette (Swab)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HEALSTONE Biotech Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000057743</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>GCHPV-502a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:56:35.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCZIK(NS1)-402aHSKU</udiDi>
    <basicUdiDi>B-GCZIK(NS1)-402aHSKU</basicUdiDi>
    <tradeName>Zika NS1 Ag Rapid Test Cassette (Whole blood/Serum/Plasma)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HEALSTONE Biotech Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000057743</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>GCZIK(NS1)-402a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:56:34.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCRE-T1402aHSGP</udiDi>
    <basicUdiDi>B-GCCRE-T1402aHSGP</basicUdiDi>
    <tradeName>CARBA 5 In 1 Rapid Test Cassette</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HEALSTONE Biotech Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000057743</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>GCCRE-T1402a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:56:18.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCDEN(NS)-402dHS46</udiDi>
    <basicUdiDi>B-GCDEN(NS)-402dHS46</basicUdiDi>
    <tradeName>Dengue NS1 Ag Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HEALSTONE Biotech Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000057743</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>GCDEN(NS)-402d</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:56:18.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GEBTA-102aHSTN</udiDi>
    <basicUdiDi>B-GEBTA-102aHSTN</basicUdiDi>
    <tradeName>Bladder Tumor Antigen Rapid Test Cassette (Urine)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HEALSTONE Biotech Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000057743</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>GEBTA-102a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:56:16.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCDEN(NS)-402cHS3Z</udiDi>
    <basicUdiDi>B-GCDEN(NS)-402cHS3Z</basicUdiDi>
    <tradeName>Dengue NS1 Ag Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HEALSTONE Biotech Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000057743</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>GCDEN(NS)-402c</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:53:39.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCTB-302aHSPC</udiDi>
    <basicUdiDi>B-GCTB-302aHSPC</basicUdiDi>
    <tradeName>Tuberculosis IgG/IgM Rapid Test Cassette (Serum/Plasma)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HEALSTONE Biotech Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000057743</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>GCTB-302a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:53:38.601Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCSYP-302aHSNJ</udiDi>
    <basicUdiDi>B-GCSYP-302aHSNJ</basicUdiDi>
    <tradeName>Syphilis Ab Rapid Test Cassette (Serum/Plasma)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HEALSTONE Biotech Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000057743</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>GCSYP-302a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:53:23.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCDEN-425aHST2</udiDi>
    <basicUdiDi>B-GCDEN-425aHST2</basicUdiDi>
    <tradeName>Dengue NS1+IgM/IgG Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HEALSTONE Biotech Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000057743</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>GCDEN-425a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:53:18.786Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMAL(pf/pv)-402aHSGS</udiDi>
    <basicUdiDi>B-GCMAL(pf/pv)-402aHSGS</basicUdiDi>
    <tradeName>Malaria P.f./P.v. Ag Rapid Test Cassette (Whole Blood)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HEALSTONE Biotech Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000057743</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>2026-09-21T20:53:18.327Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCMAL(pf/pan)-402aHSB5</udiDi>
    <basicUdiDi>B-GCMAL(pf/pan)-402aHSB5</basicUdiDi>
    <tradeName>Malaria P.f./Pan Ag Rapid Test Cassette (Whole Blood)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HEALSTONE Biotech Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000057743</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>2026-09-21T20:53:17.916Z</lastUpdated>
  </row>
</eudamedExport>