<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06952062774068</udiDi>
    <basicUdiDi>69520627J034LD</basicUdiDi>
    <tradeName>SARS-CoV-2 &amp; Influenza A+B &amp; RSV &amp; ADV Antigen Combo Test Kit (Colloidal Gold)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFRA1ST-5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T08:17:53.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952062774075</udiDi>
    <basicUdiDi>69520627J034LD</basicUdiDi>
    <tradeName>SARS-CoV-2 &amp; Influenza A+B &amp; RSV &amp; ADV Antigen Combo Test Kit (Colloidal Gold)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFRA1ST-3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T08:17:53.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952062774082</udiDi>
    <basicUdiDi>69520627J034LD</basicUdiDi>
    <tradeName>SARS-CoV-2 &amp; Influenza A+B &amp; RSV &amp; ADV Antigen Combo Test Kit (Colloidal Gold)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFRA1ST-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T08:17:53.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952062774099</udiDi>
    <basicUdiDi>69520627J034LD</basicUdiDi>
    <tradeName>SARS-CoV-2 &amp; Influenza A+B &amp; RSV &amp; ADV Antigen Combo Test Kit (Colloidal Gold)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFRA1ST-1</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T08:17:53.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349CR044GP</udiDi>
    <basicUdiDi>B-CNMF000054349CR044GP</basicUdiDi>
    <tradeName>RSV Antigen Rapid Test Kit(Colloidal gold method)</tradeName>
    <deviceName>RSV 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>W0105099002</emdnCode>
    <emdnDescription>RSV - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR044</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:08:08.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349CR017GL</udiDi>
    <basicUdiDi>B-CNMF000054349CR017GL</basicUdiDi>
    <tradeName>Monkeypox Virus Antigen Rapid Test Kit</tradeName>
    <deviceName>Monkeypox Virus Antigen Rapid Test Kit</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>W0105099008</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR017</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:07:40.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000054349CR015GG</udiDi>
    <basicUdiDi>B-CNMF000054349CR015GG</basicUdiDi>
    <tradeName>Monkeypox Virus Antibody Rapid Test Kit</tradeName>
    <deviceName>Monkeypox Virus Antibody Rapid Test Kit</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>W0105099008</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:07:38.731Z</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-CHKV-W23MC</udiDi>
    <basicUdiDi>B-CHKV-W23MC</basicUdiDi>
    <tradeName>D-CHKV-W23MC</tradeName>
    <deviceName>Chikungunya IgG/IgM Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHKV-W23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T01:05:42.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CHA-W23PR</udiDi>
    <basicUdiDi>B-CHA-W23PR</basicUdiDi>
    <tradeName>D-CHA-W23PR</tradeName>
    <deviceName>Chagas Antibody Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHA-W23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T01:05:20.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CER818VBCY</udiDi>
    <basicUdiDi>B-CER818VBCY</basicUdiDi>
    <tradeName>HPVix</tradeName>
    <deviceName>CER818VB</deviceName>
    <manufacturerName>Abcerion Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035420</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CER818VB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T01:02:05.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CER818RTDQ</udiDi>
    <basicUdiDi>B-CER818RTDQ</basicUdiDi>
    <tradeName>HPVix</tradeName>
    <deviceName>CER818RT</deviceName>
    <manufacturerName>Abcerion Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035420</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CER818RT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T01:02:04.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-IDT-B384VS</udiDi>
    <basicUdiDi>B-ABT-IDT-B384VS</basicUdiDi>
    <tradeName>Accu-Tell® COVID-19 Antigen Cassette (Saliva/ Nasopharyngeal Swab)</tradeName>
    <deviceName>Accu-Tell® COVID-19 Antigen Cassette</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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B384</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:24.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-IDT-B378VX</udiDi>
    <basicUdiDi>B-ABT-IDT-B378VX</basicUdiDi>
    <tradeName>Accu-Tell® COVID-19 Antigen Cassette (Nasal Swab/Nasopharyngeal Swab)</tradeName>
    <deviceName>Accu-Tell® COVID-19 Antigen Cassette</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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B378</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:24.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-IDT-B274VJ</udiDi>
    <basicUdiDi>B-ABT-IDT-B274VJ</basicUdiDi>
    <tradeName>Accu-Tell® Dengue NS1 Antigen Cassette (Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® Dengue NS1 Antigen Cassette</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>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B274</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:23.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ABT-IDT-B259VN</udiDi>
    <basicUdiDi>B-ABT-IDT-B259VN</basicUdiDi>
    <tradeName>Accu-Tell® Dengue IgG/IgM/NS1 Combo Cassette (Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® Dengue IgG/IgM/NS1 Combo Cassette</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>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B259</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:18.396Z</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>
</eudamedExport>