<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-TD-HNKX-CED-554E</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-554E</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-554E</tradeName>
    <deviceName>Dengue IgG &amp; IgM Antibody Kit (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:57:21.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-5044</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-5044</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-5044</tradeName>
    <deviceName>Dengue Virus Antigen Kit (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040611</emdnCode>
    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:57:02.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-303W</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-303W</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-303W</tradeName>
    <deviceName>Multiple (6 Items) Respiratory Virus Antibody Kit (Fluorescent Immunoassay)</deviceName>
    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:56:29.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-294D</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-294D</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-294D</tradeName>
    <deviceName>Multiple (4 Items) Respiratory Virus Antigen Kit (Fluorescent Immunoassay)</deviceName>
    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:56:27.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-284B</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-284B</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-284B</tradeName>
    <deviceName>Multiple (5 Items) Respiratory Virus Antigen Kit (Fluorescent Immunoassay)</deviceName>
    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:56:25.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ST08NC</udiDi>
    <basicUdiDi>B-ST08NC</basicUdiDi>
    <tradeName>Cowingene Monkeypox Virus Typing Detection Kit</tradeName>
    <deviceName>Cowingene Monkeypox Virus Typing 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>W0105040532</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX - NA REAGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST08011X, ST08012X, ST08013W</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:42:53.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ST07NA</udiDi>
    <basicUdiDi>B-ST07NA</basicUdiDi>
    <tradeName>Cowingene Monkeypox Virus Detection Kit</tradeName>
    <deviceName>Cowingene Monkeypox Virus 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>W0105040532</emdnCode>
    <emdnDescription>MONKEYPOX VIRUS / MPOX - NA REAGENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST07011X, ST07012X, ST07013W</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:42:20.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ST05N6</udiDi>
    <basicUdiDi>B-ST05N6</basicUdiDi>
    <tradeName>Cowingene Herpes Simplex Virus 1/2 Detection Kit</tradeName>
    <deviceName>Cowingene Herpes Simplex Virus 1/2 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>W0105040311</emdnCode>
    <emdnDescription>HSV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST05011X, ST05012X, ST05013W</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:40:29.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RA012UG</udiDi>
    <basicUdiDi>B-RA012UG</basicUdiDi>
    <tradeName>GENEDIAN</tradeName>
    <deviceName>SARS-CoV-2 and Influenza A/B Nucleic Acid Detection Kit</deviceName>
    <manufacturerName>Hangzhou DIAN Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007252</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P122-06048</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:54.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RA011UE</udiDi>
    <basicUdiDi>B-RA011UE</basicUdiDi>
    <tradeName>GENEDIAN</tradeName>
    <deviceName>Human Papillomavirus Nucleic Acid Detection Kit (Fluorescence PCR Method)</deviceName>
    <manufacturerName>Hangzhou DIAN Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007252</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041003</emdnCode>
    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P122-02096</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:52.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RA009UT</udiDi>
    <basicUdiDi>B-RA009UT</basicUdiDi>
    <tradeName>GENEDIAN</tradeName>
    <deviceName>SARS-CoV-2 Neutralization Antibody Detection Kit(ELISA)</deviceName>
    <manufacturerName>Hangzhou DIAN Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007252</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I121-01096; I121-01480</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:46.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RA008UR</udiDi>
    <basicUdiDi>B-RA008UR</basicUdiDi>
    <tradeName>GENEDIAN</tradeName>
    <deviceName>SARS-CoV-2 Neutralization Antibody Detection Kit</deviceName>
    <manufacturerName>Hangzhou DIAN Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007252</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L121-10120</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:45.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RA007UP</udiDi>
    <basicUdiDi>B-RA007UP</basicUdiDi>
    <tradeName>GENEDIAN</tradeName>
    <deviceName>COVID-19 Antigen Test Cassette</deviceName>
    <manufacturerName>Hangzhou DIAN Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007252</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L111-10125</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:44.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RA006UM</udiDi>
    <basicUdiDi>B-RA006UM</basicUdiDi>
    <tradeName>GENEDIAN</tradeName>
    <deviceName>Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Hangzhou DIAN Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007252</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P122-01048</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:40.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RA005UK</udiDi>
    <basicUdiDi>B-RA005UK</basicUdiDi>
    <tradeName>GENEDIAN</tradeName>
    <deviceName>Human Papillomavirus DNA Test Kit(Fluorescence Melting Curve Method)</deviceName>
    <manufacturerName>Hangzhou DIAN Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007252</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041004</emdnCode>
    <emdnDescription>FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P122-08048; P122-08240; P122-08480</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:40.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R190162Y</udiDi>
    <basicUdiDi>B-R190162Y</basicUdiDi>
    <tradeName>D-R190162Y</tradeName>
    <deviceName>Rubella Virus Antibody IgG (RV IgG) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040102</emdnCode>
    <emdnDescription>RUBELLA VIRUS IGG</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>R19016</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:24:41.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R190152W</udiDi>
    <basicUdiDi>B-R190152W</basicUdiDi>
    <tradeName>D-R190152W</tradeName>
    <deviceName>Rubella Virus Antibody IgG (RV IgG) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040102</emdnCode>
    <emdnDescription>RUBELLA VIRUS IGG</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>R19015</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:24:41.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R190142U</udiDi>
    <basicUdiDi>B-R190142U</basicUdiDi>
    <tradeName>D-R190142U</tradeName>
    <deviceName>Rubella Virus Antibody IgG (RV IgG) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040102</emdnCode>
    <emdnDescription>RUBELLA VIRUS IGG</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>R19014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:24:41.069Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R190132S</udiDi>
    <basicUdiDi>B-R190132S</basicUdiDi>
    <tradeName>D-R190132S</tradeName>
    <deviceName>Rubella Virus Antibody IgG (RV IgG) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040102</emdnCode>
    <emdnDescription>RUBELLA VIRUS IGG</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>R19013</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:24:40.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R190122Q</udiDi>
    <basicUdiDi>B-R190122Q</basicUdiDi>
    <tradeName>D-R190122Q</tradeName>
    <deviceName>Rubella Virus Antibody IgG (RV IgG) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040102</emdnCode>
    <emdnDescription>RUBELLA VIRUS IGG</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>R19012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:24:34.477Z</lastUpdated>
  </row>
</eudamedExport>