<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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-697424646ROT002RAAC</udiDi>
    <basicUdiDi>B-697424646ROT002RAAC</basicUdiDi>
    <tradeName>Rotavirus Antigen Rapid Test(Feces)</tradeName>
    <deviceName>Rotavirus 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>W0105090104</emdnCode>
    <emdnDescription>STREP. B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ROT-5011/ROT-5012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:14:42.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646ROT000R69E</udiDi>
    <basicUdiDi>B-697424646ROT000R69E</basicUdiDi>
    <tradeName>Rotavirus Rapid Test (Feces)</tradeName>
    <deviceName>Rotavirus 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>W0105090104</emdnCode>
    <emdnDescription>STREP. B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ROT-5011/ROT-5012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:14:38.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840313086</udiDi>
    <basicUdiDi>B-69743840313086</basicUdiDi>
    <tradeName>Chlamydia Rapid Test Device (Swab)</tradeName>
    <deviceName>Chlamydia Rapid Test Device (Swab)</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090101</emdnCode>
    <emdnDescription>CHLAMYDIA AG - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3020101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:13:18.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840312300</udiDi>
    <basicUdiDi>B-69743840312300</basicUdiDi>
    <tradeName>Clostridium Difficile Toxin AB+GDH Rapid Test</tradeName>
    <deviceName>Clostridium Difficile Toxin AB+GDH Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090106</emdnCode>
    <emdnDescription>CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3024703</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:12:58.090Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840312232</udiDi>
    <basicUdiDi>B-69743840312232</basicUdiDi>
    <tradeName>Clostridium Difficile Toxin A+B Rapid Test</tradeName>
    <deviceName>Clostridium Difficile Toxin A+B Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090106</emdnCode>
    <emdnDescription>CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3024701</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:12:55.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840310498</udiDi>
    <basicUdiDi>B-69743840310498</basicUdiDi>
    <tradeName>Ehrlichia Antibody Rapid Test</tradeName>
    <deviceName>Ehrlichia Antibody Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3023501</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:12:19.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840310184</udiDi>
    <basicUdiDi>B-69743840310184</basicUdiDi>
    <tradeName>Anaplasmosis Antibody Rapid Test</tradeName>
    <deviceName>Anaplasmosis Antibody Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3023401</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:12:14.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840307900</udiDi>
    <basicUdiDi>B-69743840307900</basicUdiDi>
    <tradeName>Strep A Rapid Test</tradeName>
    <deviceName>Strep A Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3021104</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:11:21.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840307832</udiDi>
    <basicUdiDi>B-69743840307832</basicUdiDi>
    <tradeName>Mycobacterium Tuberculosis Antibody Rapid Test</tradeName>
    <deviceName>Mycobacterium Tuberculosis Antibody Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3021801</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:11:21.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840303872</udiDi>
    <basicUdiDi>B-69743840303872</basicUdiDi>
    <tradeName>Typhoid Antigen Rapid Test</tradeName>
    <deviceName>Typhoid Antigen Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3021401</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:10:53.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840303704</udiDi>
    <basicUdiDi>B-69743840303704</basicUdiDi>
    <tradeName>H. pylori Antibody Rapid Test</tradeName>
    <deviceName>H. pylori Antibody Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3020501</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:10:52.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840303636</udiDi>
    <basicUdiDi>B-69743840303636</basicUdiDi>
    <tradeName>Treponema Pallidum Antibody Rapid Test</tradeName>
    <deviceName>Treponema Pallidum Antibody Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3021206</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:10:47.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840302882</udiDi>
    <basicUdiDi>B-69743840302882</basicUdiDi>
    <tradeName>H.pylori Antigen Rapid Test</tradeName>
    <deviceName>H.pylori Antigen Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3020502</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:10:34.389Z</lastUpdated>
  </row>
</eudamedExport>