<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-697424646CHO001FMT3</udiDi>
    <basicUdiDi>B-697424646CHO001FMT3</basicUdiDi>
    <tradeName>Cholera O1 Antigen Rapid Test</tradeName>
    <deviceName>Cholera O1 Antigen Rapid Test</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>CHO-5012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:03:45.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646CHO000FKSS</udiDi>
    <basicUdiDi>B-697424646CHO000FKSS</basicUdiDi>
    <tradeName>Cholera O1 Antigen Rapid Test(Feces)</tradeName>
    <deviceName>Cholera O1 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>CHO-5012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:03:45.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646BRU002L2ZB</udiDi>
    <basicUdiDi>B-697424646BRU002L2ZB</basicUdiDi>
    <tradeName>Brucella IgG/IgM Rapid Test (Serum/Plasma)</tradeName>
    <deviceName>Brucella 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>Bru-3022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:03:05.963Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646BRU001KY3J</udiDi>
    <basicUdiDi>B-697424646BRU001KY3J</basicUdiDi>
    <tradeName>Brucella IgG/IgM Rapid Test(WB/S/P)</tradeName>
    <deviceName>Brucella IgG/IgM Rapid Test(WB/S/P)</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>Bru-4022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:03:02.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646BRU000KW39</udiDi>
    <basicUdiDi>B-697424646BRU000KW39</basicUdiDi>
    <tradeName>Brucella IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Brucella IgG/IgM 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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BRU-4022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:03:01.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>60743840312859</udiDi>
    <basicUdiDi>B-60743840312859</basicUdiDi>
    <tradeName>Candida Albicans/Gardnerella Vaginalis /Trichomonas Vaginalis Combo Rapid Test（Swab）</tradeName>
    <deviceName>Candida Albicans/Gardnerella Vaginalis /Trichomonas Vaginalis Combo Rapid Test（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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3026901</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:10:30.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440200482</udiDi>
    <basicUdiDi>84354402IDXGASTROB_CA5W</basicUdiDi>
    <tradeName>CerTest Campylobacter</tradeName>
    <deviceName>CerTest Campylobacter</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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA820001V</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:19:27.267Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-nvm-611905N-102D</udiDi>
    <basicUdiDi>B-nvm-611905N-102D</basicUdiDi>
    <tradeName>NADAL® Gonorrhea Test</tradeName>
    <deviceName>Gonorrhea Test</deviceName>
    <manufacturerName>nal von minden GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013321</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>611905N-10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:28:30.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WI-GON-C71-25FZ</udiDi>
    <basicUdiDi>B-WI-GON-C71-25FZ</basicUdiDi>
    <tradeName>Bio·Firm</tradeName>
    <deviceName>Gonorrhea Rapid Test</deviceName>
    <manufacturerName>Zhejiang Wantaifu Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037582</manufacturerSrn>
    <authorisedRepresentativeName>OSEN GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000023626</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WI-GON-C71-25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:31:00.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VITB-402QD</udiDi>
    <basicUdiDi>B-VITB-402QD</basicUdiDi>
    <tradeName>Tuberculosis IgG/IgM Rapid Test</tradeName>
    <deviceName>Tuberculosis IgG/IgM Rapid Test</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</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>Piyasada</deviceStatus>
    <reference>VITB-402</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:24:24.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VILP-426SD</udiDi>
    <basicUdiDi>B-VILP-426SD</basicUdiDi>
    <tradeName>Leptospira IgG/IgM Rapid Test</tradeName>
    <deviceName>Leptospira IgG/IgM Rapid Test</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</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>Piyasada</deviceStatus>
    <reference>VILP-426</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:23:50.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TYP-D02aW5</udiDi>
    <basicUdiDi>B-TYP-D02aW5</basicUdiDi>
    <tradeName>Typhoid Antibody Rapid Test</tradeName>
    <deviceName>Typhoid Antibody Rapid Test</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TYP-D02a</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:24:35.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TE40B/S-GZ-40BTG</udiDi>
    <basicUdiDi>B-TE40B/S-GZ-40BTG</basicUdiDi>
    <tradeName>Tetanos Quick Stick</tradeName>
    <deviceName>Tetanos Quick Stick</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TE40B / S-GZ-40B</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:58:08.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TE-50UA9</udiDi>
    <basicUdiDi>B-TE-50UA9</basicUdiDi>
    <tradeName>Tetanos Quick Stick</tradeName>
    <deviceName>Tetanos Quick Stick</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TE-50U</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:58:07.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TB-D22aRH</udiDi>
    <basicUdiDi>B-TB-D22aRH</basicUdiDi>
    <tradeName>Tuberculosis (TB) IgG/IgM Rapid Test</tradeName>
    <deviceName>Tuberculosis (TB) IgG/IgM Rapid Test</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB-D22a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:54:53.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RICK-W23PR</udiDi>
    <basicUdiDi>B-RICK-W23PR</basicUdiDi>
    <tradeName>D-RICK-W23PR</tradeName>
    <deviceName>Rickettsia Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</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>Piyasada</deviceStatus>
    <reference>RICK-W23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:27:38.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MI-F42002N4</udiDi>
    <basicUdiDi>B-MI-F42002N4</basicUdiDi>
    <tradeName>D-MI-F42002N4</tradeName>
    <deviceName>Crypto/Giardia combo Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</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>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:07:30.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITB-402SL</udiDi>
    <basicUdiDi>B-ITB-402SL</basicUdiDi>
    <tradeName>D-ITB-402SL</tradeName>
    <deviceName>TB Tuberculosis Rapid Test Device (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>Abon Biopharm(Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000009171</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITB-402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:43:16.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IGV-502UC</udiDi>
    <basicUdiDi>B-IGV-502UC</basicUdiDi>
    <tradeName>D-IGV-502UC</tradeName>
    <deviceName>Gardnerella vaginalis Antigen Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IGV-502</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:09:32.396Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD136XK</udiDi>
    <basicUdiDi>B-GKPD136XK</basicUdiDi>
    <tradeName>Gardnerella vaginalis Ag Rapid Test Kit</tradeName>
    <deviceName>Gardnerella vaginalis Ag Rapid Test Kit</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD136</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:38:10.293Z</lastUpdated>
  </row>
</eudamedExport>