<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-RP23021VA5</udiDi>
    <basicUdiDi>B-RP23021VA5</basicUdiDi>
    <tradeName>Cowingene Respiratory Pathogen Panel 21  Detection Kit</tradeName>
    <deviceName>Cowingene Respiratory Pathogen Panel 21 Detection Kit</deviceName>
    <manufacturerName>Taizhou Cowingene Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042619</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RP23021V</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:28:29.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RP13MA</udiDi>
    <basicUdiDi>B-RP13MA</basicUdiDi>
    <tradeName>Cowingene Respiratory Pathogen Panel Detection Kit</tradeName>
    <deviceName>Cowingene Respiratory Pathogen Panel Detection Kit</deviceName>
    <manufacturerName>Taizhou Cowingene Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042619</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RP13021W, RP13022S, RP14021W, RP16023P, RP19023P RP14022U,</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:28:28.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RP2-P7-10YM</udiDi>
    <basicUdiDi>B-RP2-P7-10YM</basicUdiDi>
    <tradeName>Respiratory Panel 2</tradeName>
    <deviceName>Respiratory Panel 2</deviceName>
    <manufacturerName>FlashDx Shenzhen Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000025748</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RP2-P7-10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:28:28.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RP1-P10-10NG</udiDi>
    <basicUdiDi>B-RP1-P10-10NG</basicUdiDi>
    <tradeName>Respiratory Panel 1.0</tradeName>
    <deviceName>Respiratory Panel 1.0</deviceName>
    <manufacturerName>FlashDx Shenzhen Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000025748</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RP1-P10-10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:28:23.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RP11M6</udiDi>
    <basicUdiDi>B-RP11M6</basicUdiDi>
    <tradeName>Cowingene SARS-CoV-2 &amp; Influenza A/B Detection Kit</tradeName>
    <deviceName>Cowingene SARS-CoV-2 &amp; Influenza A/B Detection Kit</deviceName>
    <manufacturerName>Taizhou Cowingene Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042619</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RP11021X, RP11022X, RP11023W</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:28:22.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RP03M7</udiDi>
    <basicUdiDi>B-RP03M7</basicUdiDi>
    <tradeName>Cowingene Influenza A/B and RSV Detection Kit</tradeName>
    <deviceName>Cowingene Influenza A/B and RSV Detection Kit</deviceName>
    <manufacturerName>Taizhou Cowingene Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042619</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RP03021X, RP03022X, RP03023W</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:28:09.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RP-P10-10XX</udiDi>
    <basicUdiDi>B-RP-P10-10XX</basicUdiDi>
    <tradeName>Respiratory Panel 1.1</tradeName>
    <deviceName>Respiratory Panel 1.1</deviceName>
    <manufacturerName>FlashDx Shenzhen Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000025748</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RP-P10-10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:28:05.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809240103203</udiDi>
    <basicUdiDi>924010SD10159GU</basicUdiDi>
    <tradeName>Allplex™ Bacterial Vaginosis plus Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD10320Z</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:45:24.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809240101780</udiDi>
    <basicUdiDi>924010SD98030LF</basicUdiDi>
    <tradeName>Allplex™ Candidiasis Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD10178Z</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:45:23.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809240101575</udiDi>
    <basicUdiDi>924010SD97500LQ</basicUdiDi>
    <tradeName>Allplex™ Vaginitis screening Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD9750Y</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:45:23.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809240103210</udiDi>
    <basicUdiDi>924010SD97500LQ</basicUdiDi>
    <tradeName>Allplex™ Vaginitis screening Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD10321Z</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:45:23.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OGVPH-501aLF</udiDi>
    <basicUdiDi>B-OGVPH-501aLF</basicUdiDi>
    <tradeName>Vaginal pH Rapid Test Strip (Swab)</tradeName>
    <deviceName>Vaginal pH Rapid Test Strip (Swab)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070501</emdnCode>
    <emdnDescription>STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VPH-501a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:12:30.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NGS3104WS</udiDi>
    <basicUdiDi>B-NGS3104WS</basicUdiDi>
    <tradeName>LeoNext PP Library Prep Kit</tradeName>
    <deviceName>LeoNext PP Library Prep 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>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGS3104-01 NGS3104-02 NGS3104-03</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:22:43.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K90508ZM</udiDi>
    <basicUdiDi>B-K90508ZM</basicUdiDi>
    <tradeName>D-K90508ZM</tradeName>
    <deviceName>Influenza &amp; SARS-CoV-2  Antigen Combo Test Kit（Colloidal Gold Immunochromatographic Assay)</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:38:28.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K90411-016PC</udiDi>
    <basicUdiDi>B-K90411-016PC</basicUdiDi>
    <tradeName>D-K90411-016PC</tradeName>
    <deviceName>Procalcitonin (PCT) &amp; Interleukin-6 (IL-6) Combo Test Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:37:22.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K90411-015PA</udiDi>
    <basicUdiDi>B-K90411-015PA</basicUdiDi>
    <tradeName>D-K90411-015PA</tradeName>
    <deviceName>Serum Amyloid A (SAA) &amp; Full C-reactive protein (CRP) Combo Test Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:37:21.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K90411-014P8</udiDi>
    <basicUdiDi>B-K90411-014P8</basicUdiDi>
    <tradeName>D-K90411-014P8</tradeName>
    <deviceName>Procalcitonin (PCT) &amp; Full C-reactive protein (CRP) Combo Test Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:37:20.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-K12-RVPanel4CU</udiDi>
    <basicUdiDi>B-K12-RVPanel4CU</basicUdiDi>
    <tradeName>InfectCheck SARS-CoV-2/RSV/FluA/FluB</tradeName>
    <deviceName>SARS-CoV-2/RSV/ FluA/ FluB Antigen Rapid Test</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>811028/ K12-RVPanel4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:36:34.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-JC30302NW-50TRB</udiDi>
    <basicUdiDi>B-JC30302NW-50TRB</basicUdiDi>
    <tradeName>Zika Virus/Dengue Virus/Chikungunya Virus Real Time PCR Kit</tradeName>
    <deviceName>Zika Virus/Dengue Virus/Chikungunya Virus Real Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JC30302NW-50T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:23:51.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-JC30302NW-25TRB</udiDi>
    <basicUdiDi>B-JC30302NW-25TRB</basicUdiDi>
    <tradeName>Zika Virus/Dengue Virus/Chikungunya Virus Real Time PCR Kit</tradeName>
    <deviceName>Zika Virus/Dengue Virus/Chikungunya Virus Real Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JC30302NW-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:23:50.482Z</lastUpdated>
  </row>
</eudamedExport>