<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800097500085</udiDi>
    <basicUdiDi>880009750008D7</basicUdiDi>
    <tradeName>PaxView DNA Extraction Kit</tradeName>
    <deviceName>PaxView DNA Extraction Kit</deviceName>
    <manufacturerName>PaxGenBio Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000024696</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V0101F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:29:26.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800097500009</udiDi>
    <basicUdiDi>B-08800097500009</basicUdiDi>
    <tradeName>PaxView TB/NTM MPCR-ULFA Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PaxGenBio Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000024696</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>V0401</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:05:39.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800097500016</udiDi>
    <basicUdiDi>B-08800097500016</basicUdiDi>
    <tradeName>PaxView HPV16/HPV18 MPCR-ULFA Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PaxGenBio Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000024696</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>V0330</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:05:39.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800097500023</udiDi>
    <basicUdiDi>B-08800097500023</basicUdiDi>
    <tradeName>PaxView® SARS-CoV-2 real-time RT-PCR Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PaxGenBio Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000024696</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>R0502</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:05:38.990Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800097500030</udiDi>
    <basicUdiDi>B-08800097500030</basicUdiDi>
    <tradeName>PaxView HPV16/18/Others MPCR-ULFA Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PaxGenBio Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000024696</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>V0301</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:05:38.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800097500047</udiDi>
    <basicUdiDi>B-08800097500047</basicUdiDi>
    <tradeName>PaxView HPV20 Genotyping MPCR-ULFA Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PaxGenBio Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000024696</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>V0324</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:05:38.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800097500115</udiDi>
    <basicUdiDi>B-08800097500115</basicUdiDi>
    <tradeName>PaxView TB MPCR-ULFA Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PaxGenBio Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000024696</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>V0431</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:05:38.952Z</lastUpdated>
  </row>
</eudamedExport>