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<eudamedExport entity="devices">
  <row>
    <udiDi>D-697424646HSV000NW82</udiDi>
    <basicUdiDi>B-697424646HSV000NW82</basicUdiDi>
    <tradeName>Herpes simplex virus Rapid Test (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Herpes simplex virus Rapid Test (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HSV-4022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:07:08.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646CHIK001N596</udiDi>
    <basicUdiDi>B-697424646CHIK001N596</basicUdiDi>
    <tradeName>Chikungunya IgG/IgM Rapid Test(Serum/Plasma)</tradeName>
    <deviceName>Chikungunya IgG/IgM Rapid Test(Serum/Plasma)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHIK-3022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:03:44.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646CHIK000N38V</udiDi>
    <basicUdiDi>B-697424646CHIK000N38V</basicUdiDi>
    <tradeName>Chikungunya IgG/IgM Rapid Test(Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Chikungunya IgG/IgM Rapid Test(Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHIK-4022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:03:39.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646ADV001EYT9</udiDi>
    <basicUdiDi>B-697424646ADV001EYT9</basicUdiDi>
    <tradeName>Adenovirus Antigen Rapid Test (Feces)</tradeName>
    <deviceName>Adenovirus Antigen Rapid Test (Feces)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADV-5011/ADV-5012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:02:31.450Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646ADV000EWSY</udiDi>
    <basicUdiDi>B-697424646ADV000EWSY</basicUdiDi>
    <tradeName>Adenovirus Rapid Test (Feces)</tradeName>
    <deviceName>Adenovirus Rapid Test (Feces)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADV-5011/ADV-5012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:02:31.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69384449ROTA3Y</udiDi>
    <basicUdiDi>B-69384449ROTA3Y</basicUdiDi>
    <tradeName>D-69384449ROTA3Y</tradeName>
    <deviceName>One Step Rotavirus Test</deviceName>
    <manufacturerName>Equinox Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018901</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RH-ROTA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:51:42.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976232252149</udiDi>
    <basicUdiDi>B-06976232252149</basicUdiDi>
    <tradeName>Acmex</tradeName>
    <deviceName>Adenovirus (AV) intestinal rapid test</deviceName>
    <manufacturerName>Acmex Bio-Technology (Chongqing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037745</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA03-14-422P25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:32:40.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976232252132</udiDi>
    <basicUdiDi>B-06976232252132</basicUdiDi>
    <tradeName>Acmex</tradeName>
    <deviceName>Rotavirus (RV) intestinal rapid test</deviceName>
    <manufacturerName>Acmex Bio-Technology (Chongqing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037745</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA03-15-422P25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:32:38.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976232252125</udiDi>
    <basicUdiDi>B-06976232252125</basicUdiDi>
    <tradeName>Acmex</tradeName>
    <deviceName>Adenovirus respiratory Rapid Test</deviceName>
    <manufacturerName>Acmex Bio-Technology (Chongqing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037745</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA03-16-422P2</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:32:38.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976232251838</udiDi>
    <basicUdiDi>B-06976232251838</basicUdiDi>
    <tradeName>Acmex</tradeName>
    <deviceName>Adenovirus and Rotavirus (AV-RV) Combo Test</deviceName>
    <manufacturerName>Acmex Bio-Technology (Chongqing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037745</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA03-17-422P25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:32:02.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952062777816</udiDi>
    <basicUdiDi>B-06952062777816</basicUdiDi>
    <tradeName>COVID-19 (SARS-CoV-2)Antigen Test Kit(Colloidal Gold)Saliva</tradeName>
    <deviceName>COVID-19 (SARS-CoV-2)Antigen Test Kit(Colloidal Gold)Saliva</deviceName>
    <manufacturerName>ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000018785</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL030101SST-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:56:56.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440206002</udiDi>
    <basicUdiDi>84354402IDXGASTROB_NN7R</basicUdiDi>
    <tradeName>CerTest Norovirus</tradeName>
    <deviceName>CerTest Norovirus</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NN820001V</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:19:36.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440205982</udiDi>
    <basicUdiDi>84354402IDXGASTROB_RT8H</basicUdiDi>
    <tradeName>CerTest Rotavirus+Adenovirus+Astrovirus</tradeName>
    <deviceName>CerTest Rotavirus+Adenovirus+Astrovirus</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RT872001V</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:19:34.069Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440200277</udiDi>
    <basicUdiDi>84354402IDXGASTROB_RG7P</basicUdiDi>
    <tradeName>CerTest Rota+Adeno+Astro+Noro</tradeName>
    <deviceName>CerTest Rota+Adeno+Astro+Noro</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RG862001V</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:19:05.799Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440200260</udiDi>
    <basicUdiDi>84354402IDXGASTROB_RA7B</basicUdiDi>
    <tradeName>CerTest ROTA+ADENO+NORO</tradeName>
    <deviceName>CerTest ROTA+ADENO+NORO</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RA872001V</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:19:04.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440200253</udiDi>
    <basicUdiDi>84354402IDXGASTROB_RN85</basicUdiDi>
    <tradeName>CerTest Rotavirus+Norovirus GI/GII</tradeName>
    <deviceName>CerTest Rotavirus+Norovirus GI/GII</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RN882001V</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:19:01.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440200246</udiDi>
    <basicUdiDi>84354402IDXGASTROB_NV89</basicUdiDi>
    <tradeName>CerTest Norovirus GI+GII</tradeName>
    <deviceName>CerTest Norovirus GI+GII</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NV882001V</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:18:59.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440200208</udiDi>
    <basicUdiDi>84354402IDXGASTROB_AT6W</basicUdiDi>
    <tradeName>CerTest Astrovirus</tradeName>
    <deviceName>CerTest Astrovirus</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AT820001V</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:18:59.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440200185</udiDi>
    <basicUdiDi>84354402IDXGASTROB_XR8X</basicUdiDi>
    <tradeName>CerTest Rotavirus+Adenovirus</tradeName>
    <deviceName>CerTest Rotavirus+Adenovirus</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XR882001V</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:18:57.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440200161</udiDi>
    <basicUdiDi>84354402IDXGASTROB_AD5W</basicUdiDi>
    <tradeName>CerTest Adenovirus</tradeName>
    <deviceName>CerTest Adenovirus</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD820001V</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:18:55.101Z</lastUpdated>
  </row>
</eudamedExport>