<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08908015304965</udiDi>
    <basicUdiDi>89080153043B1271L7</basicUdiDi>
    <tradeName>TRUPCR® TORCH Panel Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1272</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:20:06.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908015304989</udiDi>
    <basicUdiDi>89080153043B1271L7</basicUdiDi>
    <tradeName>TRUPCR® TORCH Panel Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1271</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:20:06.615Z</lastUpdated>
  </row>
  <row>
    <udiDi>10190302019071</udiDi>
    <basicUdiDi>0190302A56125SA</basicUdiDi>
    <tradeName>TaqPath™ COVID 19, Flu A, Flu B, RSV Select Positive Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Life Technologies Corporation; Thermo Fisher Life Sciences</manufacturerName>
    <manufacturerSrn>US-MF-000026189</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>963611 (A56125)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T07:50:52.420Z</lastUpdated>
  </row>
  <row>
    <udiDi>10190302019088</udiDi>
    <basicUdiDi>0190302A56125SA</basicUdiDi>
    <tradeName>TaqPath™ COVID 19, Flu A, Flu B, RSV Select Negative Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Life Technologies Corporation; Thermo Fisher Life Sciences</manufacturerName>
    <manufacturerSrn>US-MF-000026189</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>963610 (A56125)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T07:50:52.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>10190302019095</udiDi>
    <basicUdiDi>0190302A56125SA</basicUdiDi>
    <tradeName>TaqPath™ 1-Step Select Master Mix (No ROX)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Life Technologies Corporation; Thermo Fisher Life Sciences</manufacturerName>
    <manufacturerSrn>US-MF-000026189</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>A56520 (A56125)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T07:50:52.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792731905</udiDi>
    <basicUdiDi>B-06955792731905</basicUdiDi>
    <tradeName>06955792731905</tradeName>
    <deviceName>Adenovirus and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3335E-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:32:37.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792731899</udiDi>
    <basicUdiDi>B-06955792731899</basicUdiDi>
    <tradeName>06955792731899</tradeName>
    <deviceName>Adenovirus and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3335E-24</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:32:32.510Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792731349</udiDi>
    <basicUdiDi>B-06955792731349</basicUdiDi>
    <tradeName>06955792731349</tradeName>
    <deviceName>SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3113E-24-P</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:30:59.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792731332</udiDi>
    <basicUdiDi>B-06955792731332</basicUdiDi>
    <tradeName>SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3113E-48</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:30:58.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792731325</udiDi>
    <basicUdiDi>B-06955792731325</basicUdiDi>
    <tradeName>SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3113E-24</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:30:56.169Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792730526</udiDi>
    <basicUdiDi>B-06955792730526</basicUdiDi>
    <tradeName>06955792730526</tradeName>
    <deviceName>SARS-CoV-2/InFluA/InFluB Rapid Antigen Test (Immunochromatography Assay)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3121E-25</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:28:10.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792714649</udiDi>
    <basicUdiDi>B-06955792714649</basicUdiDi>
    <tradeName>06955792714649</tradeName>
    <deviceName>SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3113E-12-S</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:27:17.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954414751871</udiDi>
    <basicUdiDi>695441479706KS</basicUdiDi>
    <tradeName>Akso SARS-CoV-2/FluA/FluB Real-time RT-PCR Kit</tradeName>
    <deviceName>Akso SARS-CoV-2/FluA/FluB Real-time RT-PCR Kit</deviceName>
    <manufacturerName>Getein Biotech, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017986</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RT6005</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T15:30:36.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954414751864</udiDi>
    <basicUdiDi>695441479706KS</basicUdiDi>
    <tradeName>Akso SARS-CoV-2/FluA/FluB Real-time RT-PCR Kit</tradeName>
    <deviceName>Akso SARS-CoV-2/FluA/FluB Real-time RT-PCR Kit</deviceName>
    <manufacturerName>Getein Biotech, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017986</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RT6005</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T15:30:34.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532679915936</udiDi>
    <basicUdiDi>353267F00189P9B</basicUdiDi>
    <tradeName>BIOSYNEX AMPLIQUICK Fecal Virology</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3150047_SEC02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T08:40:30.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532679915943</udiDi>
    <basicUdiDi>353267F00189P9B</basicUdiDi>
    <tradeName>BIOSYNEX AMPLIQUICK Fecal Virology</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3150047_BLK96</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T08:40:30.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952062712350</udiDi>
    <basicUdiDi>69520627J163LR</basicUdiDi>
    <tradeName>COVID-19&amp; Influenza A+B &amp; RSV Antigen Combo Test Kit (LFA)</tradeName>
    <deviceName>COVID-19&amp; Influenza A+B &amp; RSV Antigen Combo Test Kit (LFA)</deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</manufacturerSrn>
    <authorisedRepresentativeName>Mega Eurostar Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000042730</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFR1NST-10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T08:22:35.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952062712343</udiDi>
    <basicUdiDi>69520627J163LR</basicUdiDi>
    <tradeName>COVID-19&amp; Influenza A+B &amp; RSV Antigen Combo Test Kit (LFA)</tradeName>
    <deviceName>COVID-19&amp; Influenza A+B &amp; RSV Antigen Combo Test Kit (LFA)</deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</manufacturerSrn>
    <authorisedRepresentativeName>Mega Eurostar Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000042730</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFR1NST-5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T08:22:34.450Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952062712336</udiDi>
    <basicUdiDi>69520627J163LR</basicUdiDi>
    <tradeName>COVID-19&amp; Influenza A+B &amp; RSV Antigen Combo Test Kit (LFA)</tradeName>
    <deviceName>COVID-19&amp; Influenza A+B &amp; RSV Antigen Combo Test Kit (LFA)</deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</manufacturerSrn>
    <authorisedRepresentativeName>Mega Eurostar Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000042730</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFR1NST-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T08:22:28.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952062712329</udiDi>
    <basicUdiDi>69520627J163LR</basicUdiDi>
    <tradeName>COVID-19&amp; Influenza A+B &amp; RSV Antigen Combo Test Kit (LFA)</tradeName>
    <deviceName>COVID-19&amp; Influenza A+B &amp; RSV Antigen Combo Test Kit (LFA)</deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</manufacturerSrn>
    <authorisedRepresentativeName>Mega Eurostar Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000042730</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFR1NST-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T08:22:27.312Z</lastUpdated>
  </row>
</eudamedExport>