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<eudamedExport entity="devices">
  <row>
    <udiDi>D-697603130101A0201EG7SK</udiDi>
    <basicUdiDi>B-697603130101A0201EG7SK</basicUdiDi>
    <tradeName>D-697603130101A0201EG7SK</tradeName>
    <deviceName>Influenza A/B Virus Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Hangzhou Danwei Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041344</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>101A0201EY,101A0201ED</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:16.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646ZIKA001Z9QN</udiDi>
    <basicUdiDi>B-697424646ZIKA001Z9QN</basicUdiDi>
    <tradeName>Zika IgM/IgG Rapid Test(Serum/Plasma)</tradeName>
    <deviceName>Zika IgM/IgG 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>ZIKA-3022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:16:35.069Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646ZIKA000Z7QD</udiDi>
    <basicUdiDi>B-697424646ZIKA000Z7QD</basicUdiDi>
    <tradeName>Zika IgM/IgG Rapid Test(Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Zika IgM/IgG 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>ZIKA-4022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:16:35.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646TYP004USGX</udiDi>
    <basicUdiDi>B-697424646TYP004USGX</basicUdiDi>
    <tradeName>Typhoid IgG/IgM Rapid Test (Serum/Plasma)</tradeName>
    <deviceName>Typhoid 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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TYP-3022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:16:05.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646TYP003UQGN</udiDi>
    <basicUdiDi>B-697424646TYP003UQGN</basicUdiDi>
    <tradeName>Typhoid IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Typhoid 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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TYP-4022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:16:03.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646TYP002UNGB</udiDi>
    <basicUdiDi>B-697424646TYP002UNGB</basicUdiDi>
    <tradeName>S.Typhi(TYP) Antigen Rapid Test (Feces)</tradeName>
    <deviceName>S.Typhi(TYP) 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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TYP Ag-5012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:15:59.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646TYP000UJFR</udiDi>
    <basicUdiDi>B-697424646TYP000UJFR</basicUdiDi>
    <tradeName>Typhoid IgG/IgM Rapid Test Kit (Whole Blood/serum/plasma)</tradeName>
    <deviceName>Typhoid IgG/IgM Rapid Test Kit (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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TYP-4022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:15:58.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646TYP(F)000UJVY</udiDi>
    <basicUdiDi>B-697424646TYP(F)000UJVY</basicUdiDi>
    <tradeName>S.Typhi Antigen Rapid Test  (Feces)</tradeName>
    <deviceName>S.Typhi Antigen 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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TYP Ag-5012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:15:57.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646TB002GWKG</udiDi>
    <basicUdiDi>B-697424646TB002GWKG</basicUdiDi>
    <tradeName>Tuberculosis Rapid Test (Serum/Plasma)</tradeName>
    <deviceName>Tuberculosis 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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB-3011/TB-3012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:15:37.270Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646TB001GUK7</udiDi>
    <basicUdiDi>B-697424646TB001GUK7</basicUdiDi>
    <tradeName>Tuberculosis Rapid Test (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Tuberculosis 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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB-4011/TB-4012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:15:36.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646TB000GSJW</udiDi>
    <basicUdiDi>B-697424646TB000GSJW</basicUdiDi>
    <tradeName>Tuberculosis Rapid Test Kit(Whole Blood/serum/plasma)</tradeName>
    <deviceName>Tuberculosis Rapid Test Kit(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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB-4011/TB-4012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:15:35.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646SYP002U9EG</udiDi>
    <basicUdiDi>B-697424646SYP002U9EG</basicUdiDi>
    <tradeName>Syphilis Rapid Test (Serum/Plasma)</tradeName>
    <deviceName>Syphilis 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>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SYP-3011/SYP-4011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:15:29.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646SYP001U7E7</udiDi>
    <basicUdiDi>B-697424646SYP001U7E7</basicUdiDi>
    <tradeName>Syphilis Rapid Test (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Syphilis 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>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SYP-4011/SYP-4012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:15:12.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646SYP000U5DW</udiDi>
    <basicUdiDi>B-697424646SYP000U5DW</basicUdiDi>
    <tradeName>Syphilis Rapid Test Kit(Whole Blood/serum/plasma)</tradeName>
    <deviceName>Syphilis Rapid Test Kit(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>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SYP-4011/SYP-3011/SYP-4012/SYP-3012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:15:11.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646STB001PE67</udiDi>
    <basicUdiDi>B-697424646STB001PE67</basicUdiDi>
    <tradeName>Strep B Rapid Test (Swab)</tradeName>
    <deviceName>Strep B Rapid Test (Swab)</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>W0105090104</emdnCode>
    <emdnDescription>STREP. B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STB-6011/STB-6012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:15:07.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646STB000PC5W</udiDi>
    <basicUdiDi>B-697424646STB000PC5W</basicUdiDi>
    <tradeName>Strep B Rapid Test Kit (swab)</tradeName>
    <deviceName>Strep B Rapid Test Kit (swab)</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>W0105090104</emdnCode>
    <emdnDescription>STREP. B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STB-6011/STB-6012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:15:04.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646STA001P74Y</udiDi>
    <basicUdiDi>B-697424646STA001P74Y</basicUdiDi>
    <tradeName>Strep A Rapid Test (Swab)</tradeName>
    <deviceName>Strep A Rapid Test (Swab)</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>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STA-6011/STA-6012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:15:03.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646STA000P54P</udiDi>
    <basicUdiDi>B-697424646STA000P54P</basicUdiDi>
    <tradeName>Strep A Rapid Test Kit (swab)</tradeName>
    <deviceName>Strep A Rapid Test Kit (swab)</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>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STA-6011/STA-6012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:15:03.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646RV001LJS2</udiDi>
    <basicUdiDi>B-697424646RV001LJS2</basicUdiDi>
    <tradeName>Rubella.Virus(RV) IgM/IgG  Test(Serum/Plasma)</tradeName>
    <deviceName>Rubella.Virus(RV) IgM/IgG  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>RV-3022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:14:49.957Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646RV000LGRP</udiDi>
    <basicUdiDi>B-697424646RV000LGRP</basicUdiDi>
    <tradeName>Rubella.Virus(RV) IgM/IgG Test(Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Rubella.Virus(RV) IgM/IgG 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>RV-4022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:14:49.691Z</lastUpdated>
  </row>
</eudamedExport>