<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-GEBTA-102aHGSW</udiDi>
    <basicUdiDi>B-GEBTA-102aHGSW</basicUdiDi>
    <tradeName>Bladder Tumor Antigen Rapid Test Cassette (Urine)</tradeName>
    <deviceName>Bladder Tumor Antigen Rapid Test Cassette (Urine)</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>W0102160201</emdnCode>
    <emdnDescription>BTA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GEBTA-102a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:34:27.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>03800502152088</udiDi>
    <basicUdiDi>B-03800502152088</basicUdiDi>
    <tradeName>Lepzi BTA Test</tradeName>
    <deviceName>Lepzi BTA Test</deviceName>
    <manufacturerName>Lepzi Diagnostika Ltd.</manufacturerName>
    <manufacturerSrn>BG-MF-000051504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160201</emdnCode>
    <emdnDescription>BTA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LD_BG006</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:36:46.647Z</lastUpdated>
  </row>
</eudamedExport>