<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800061800296</udiDi>
    <basicUdiDi>88000618W010509CHR20ZL</basicUdiDi>
    <tradeName>AllCheck Syphilis Anti-TP</tradeName>
    <deviceName>AllCheck Syphilis Anti-TP</deviceName>
    <manufacturerName>CALTH Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000044697</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHR20</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T02:21:43.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800061800425</udiDi>
    <basicUdiDi>B-08800061800425</basicUdiDi>
    <tradeName>Allcheck COVID-19 Ag</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CALTH Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000044697</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHR11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T01:44:47.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800061800470</udiDi>
    <basicUdiDi>B-08800061800470</basicUdiDi>
    <tradeName>Allcheck Influenza A+B</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CALTH Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000044697</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHR08</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T01:44:47.384Z</lastUpdated>
  </row>
</eudamedExport>