<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-GCFLU(A/B)-501aHG5U</udiDi>
    <basicUdiDi>B-GCFLU(A/B)-501aHG5U</basicUdiDi>
    <tradeName>Influenza A &amp; B Ag Rapid Test Strip (Swab)</tradeName>
    <deviceName>Influenza A &amp; B Ag Rapid Test Strip (Swab)</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>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCFLU(A/B)-501a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:26:49.743Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCFLU(A/B)-501aAB</udiDi>
    <basicUdiDi>B-GCFLU(A/B)-501aAB</basicUdiDi>
    <tradeName>Influenza A &amp; B Ag Rapid Test Strip (Swab)</tradeName>
    <deviceName>Influenza A &amp; B Ag Rapid Test Strip (Swab)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCFLU(A/B)-501a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:26:48.944Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCFLU(A)-501aWQ</udiDi>
    <basicUdiDi>B-GCFLU(A)-501aWQ</basicUdiDi>
    <tradeName>Influenza A Ag Rapid Test Strip (Swab)</tradeName>
    <deviceName>Influenza A Ag Rapid Test Strip (Swab)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCFLU(A)-501a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:26:45.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2M706021F5</udiDi>
    <basicUdiDi>B-G2M706021F5</basicUdiDi>
    <tradeName>Influenza A/B-Q Real Time PCR Kit</tradeName>
    <deviceName>Influenza A/B-Q Real Time PCR Kit</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M706021, G2M706021R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:43:49.106Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FLU-B22bGV</udiDi>
    <basicUdiDi>B-FLU-B22bGV</basicUdiDi>
    <tradeName>Influenza A+B Antigen Rapid Test</tradeName>
    <deviceName>Influenza A+B Antigen Rapid Test</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FLU-B22b</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:36:21.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FLU-522bE9</udiDi>
    <basicUdiDi>B-FLU-522bE9</basicUdiDi>
    <tradeName>Influenza A/B Antigen Rapid Test</tradeName>
    <deviceName>Influenza A/B Antigen Rapid Test</deviceName>
    <manufacturerName>Medotex Biotech (HangZhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051631</manufacturerSrn>
    <authorisedRepresentativeName>Llins Service &amp; Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009077</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FLU-522b</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:36:19.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349CR006GF</udiDi>
    <basicUdiDi>B-CNMF000054349CR006GF</basicUdiDi>
    <tradeName>FluA/FluB Antigen Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>FluA/FluB Antigen Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Synthgene (Yixing) Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054349</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:07:28.308Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNM0000180720007M2</udiDi>
    <basicUdiDi>B-CNM0000180720007M2</basicUdiDi>
    <tradeName>Chemtrue ®® Influenza A+B Antigen Combo Rapid Test (Lateral Flow)</tradeName>
    <deviceName>Influenza A+B Antigen Combo Rapid Test (Lateral Flow)</deviceName>
    <manufacturerName>Shanghai Chemtron Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018072</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8010C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:10:20.040Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CIRC-02TX</udiDi>
    <basicUdiDi>B-CIRC-02TX</basicUdiDi>
    <tradeName>Covid-19 + Influenza A/B + RSV Combo Rapid Test</tradeName>
    <deviceName>Covid-19 + Influenza A/B + RSV Combo Rapid Test</deviceName>
    <manufacturerName>Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000020377</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CIRC-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:05:37.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CIC-025X</udiDi>
    <basicUdiDi>B-CIC-025X</basicUdiDi>
    <tradeName>Covid-19 + Influenza A/B Combo Rapid Test</tradeName>
    <deviceName>Covid-19 + Influenza A/B Combo Rapid Test</deviceName>
    <manufacturerName>Nano Diagnosis for Health Biotech (Guangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000020377</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CIC-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:05:33.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-IDT-A247V8</udiDi>
    <basicUdiDi>B-ABT-IDT-A247V8</basicUdiDi>
    <tradeName>Accu-Tell® Influenza A+B Strip (Swab/ Nasal Aspirate)</tradeName>
    <deviceName>Accu-Tell® Influenza A+B Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-A247</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:09.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81649002AIAH501DC9SA</udiDi>
    <basicUdiDi>B-81649002AIAH501DC9SA</basicUdiDi>
    <tradeName>D-81649002AIAH501DC9SA</tradeName>
    <deviceName>Influenza A Virus and H5 Subtype Fluorescence PCR Kit (Lyophilized)</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>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AIAH501D-AHG48E; AIAH501D-AHG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:00:21.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81649002AFAB03D6VFC</udiDi>
    <basicUdiDi>B-81649002AFAB03D6VFC</basicUdiDi>
    <tradeName>D-81649002AFAB03D6VFC</tradeName>
    <deviceName>Influenza A/B Virus Fluorescence PCR Kit (Lyophilized)</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>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFAB03D-AHG48E; AFAB03D-AHG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:59:43.076Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81649002AFAB038S9K</udiDi>
    <basicUdiDi>B-81649002AFAB038S9K</basicUdiDi>
    <tradeName>D-81649002AFAB038S9K</tradeName>
    <deviceName>Influenza A/B Virus Detection Kit (Fluorescence PCR)</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>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFAB03-AHG48E; AFAB03-AHG96E; AFAB03D-AHG48E; AFAB03D-AHG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:59:42.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81649002AFAB018N8X</udiDi>
    <basicUdiDi>B-81649002AFAB018N8X</basicUdiDi>
    <tradeName>D-81649002AFAB018N8X</tradeName>
    <deviceName>Influenza A/B  Detection Kit (Direct Fluorescence PCR)</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>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFAB01-AHG48E; AFAB01-AHG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:59:41.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-808051Q8</udiDi>
    <basicUdiDi>B-808051Q8</basicUdiDi>
    <tradeName>D-808051Q8</tradeName>
    <deviceName>Flu A &amp; Flu B Rapid Test</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808051</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:54:00.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-808050Q6</udiDi>
    <basicUdiDi>B-808050Q6</basicUdiDi>
    <tradeName>D-808050Q6</tradeName>
    <deviceName>Flu B Rapid Test</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:54:00.145Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-808049QM</udiDi>
    <basicUdiDi>B-808049QM</basicUdiDi>
    <tradeName>D-808049QM</tradeName>
    <deviceName>Flu A Rapid Test</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808049</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:53:59.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>16974198353013</udiDi>
    <basicUdiDi>B-16974198353013</basicUdiDi>
    <tradeName>16974198353013</tradeName>
    <deviceName>FLU A+B Antigen combo Rapid Test</deviceName>
    <manufacturerName>Hangzhou Higene Biotechnology Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000029811</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>nFLuAG</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:04:28.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698600057</udiDi>
    <basicUdiDi>B-16972698600057</basicUdiDi>
    <tradeName>Flu A+B Antigen Rapid Test Device</tradeName>
    <deviceName>Flu A+B Antigen Rapid Test Device</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P212102</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:50:19.373Z</lastUpdated>
  </row>
</eudamedExport>