<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-KP2D7</udiDi>
    <basicUdiDi>B-KP2D7</basicUdiDi>
    <tradeName>Pneumo CEL Indirect IFA</tradeName>
    <deviceName>Pneumo CEL Indirect IFA</deviceName>
    <manufacturerName>Cellabs Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000030640</manufacturerSrn>
    <authorisedRepresentativeName>WMDE B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002062</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104050201</emdnCode>
    <emdnDescription>PNEUMOCYSTIS JIROVECII (PNEUMOCYSTIS CARINII)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KP2</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:40:28.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885019710674</udiDi>
    <basicUdiDi>B-08885019710674</basicUdiDi>
    <tradeName>08885019710674</tradeName>
    <deviceName>abTES™ PJP Quantitative qPCR I Kit (100 Reactions)</deviceName>
    <manufacturerName>AITbiotech Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000003510</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104050201</emdnCode>
    <emdnDescription>PNEUMOCYSTIS JIROVECII (PNEUMOCYSTIS CARINII)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300208</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:20:13.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885019710667</udiDi>
    <basicUdiDi>B-08885019710667</basicUdiDi>
    <tradeName>08885019710667</tradeName>
    <deviceName>abTES™ PJP Quantitative qPCR I Kit (50 Reactions)</deviceName>
    <manufacturerName>AITbiotech Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000003510</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104050201</emdnCode>
    <emdnDescription>PNEUMOCYSTIS JIROVECII (PNEUMOCYSTIS CARINII)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300207</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:20:11.396Z</lastUpdated>
  </row>
  <row>
    <udiDi>08719326750941</udiDi>
    <basicUdiDi>B-08719326750941</basicUdiDi>
    <tradeName>PneumoGenius® Multiplex real-time PCR kit</tradeName>
    <deviceName>PneumoGenius® Multiplex real-time PCR kit</deviceName>
    <manufacturerName>PathoNostics B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000002705</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104050201</emdnCode>
    <emdnDescription>PNEUMOCYSTIS JIROVECII (PNEUMOCYSTIS CARINII)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PN-600</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:05:08.954Z</lastUpdated>
  </row>
</eudamedExport>