<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-A066DD</udiDi>
    <basicUdiDi>B-A066DD</basicUdiDi>
    <tradeName>D-A066DD</tradeName>
    <deviceName>INDICAID™ Chikungunya Rapid Antigen Test</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</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>INDICAID™ Chikungunya Rapid Antigen Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:43:20.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Ir0353FDB</udiDi>
    <basicUdiDi>B-697994388Ir0353FDB</basicUdiDi>
    <tradeName>D-697994388Ir0353FDB</tradeName>
    <deviceName>Adenovirus/Rotavirus Ag Test Panel</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir035</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:24:03.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Ir0333BCR</udiDi>
    <basicUdiDi>B-697994388Ir0333BCR</basicUdiDi>
    <tradeName>D-697994388Ir0333BCR</tradeName>
    <deviceName>Adenovirus Ag Test Kit</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir033</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:23:53.944Z</lastUpdated>
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  <row>
    <udiDi>D-697994388Ir02134BE</udiDi>
    <basicUdiDi>B-697994388Ir02134BE</basicUdiDi>
    <tradeName>D-697994388Ir02134BE</tradeName>
    <deviceName>Human Papillomavirus (HPV) Antigen Test Kit</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:23:24.026Z</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-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>
  <row>
    <udiDi>D-697424646ROT003RCAM</udiDi>
    <basicUdiDi>B-697424646ROT003RCAM</basicUdiDi>
    <tradeName>Rotavirus-Adenovirus Combo Rapid Test (Feces)</tradeName>
    <deviceName>Rotavirus-Adenovirus Combo 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>ROT-5022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:14:42.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646ROT001R89P</udiDi>
    <basicUdiDi>B-697424646ROT001R89P</basicUdiDi>
    <tradeName>Rotavirus-Adenovirus Combo Rapid Test  Kit(Feces)</tradeName>
    <deviceName>Rotavirus-Adenovirus Combo Rapid Test  Kit(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>ROT-5022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:14:41.885Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646NORO000FEDFB</udiDi>
    <basicUdiDi>B-697424646NORO000FEDFB</basicUdiDi>
    <tradeName>Norovirus Antigen FIA Test (Feces)</tradeName>
    <deviceName>Norovirus Antigen FIA 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>NORO-5012F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:13:59.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840312928</udiDi>
    <basicUdiDi>B-69743840312928</basicUdiDi>
    <tradeName>Yellow Fever Ag/IGG IGM Rapid Test (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Yellow Fever Ag/IGG IGM Rapid Test (Whole Blood/Serum/Plasma)</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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3023803</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:13:22.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840309980</udiDi>
    <basicUdiDi>B-69743840309980</basicUdiDi>
    <tradeName>Rubella IgG IgM Antibody Rapid Test</tradeName>
    <deviceName>Rubella IgG IgM 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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3022801</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:12:12.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646MID001aP6AR</udiDi>
    <basicUdiDi>B-697424646MID001aP6AR</basicUdiDi>
    <tradeName>Rotavirus-Adenovirus-Norovirus-Astrovirus Combo Rapid Test(Feces)</tradeName>
    <deviceName>Rotavirus-Adenovirus-Norovirus-Astrovirus Combo 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>MID-5042</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:09:15.903Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646MID000bP5AM</udiDi>
    <basicUdiDi>B-697424646MID000bP5AM</basicUdiDi>
    <tradeName>Rotavirus-Adenovirus-Astrovirus Combo Rapid Test (Feces)</tradeName>
    <deviceName>Rotavirus-Adenovirus-Astrovirus Combo 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>MID-5032b</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:09:07.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646MID000aP3AC</udiDi>
    <basicUdiDi>B-697424646MID000aP3AC</basicUdiDi>
    <tradeName>Rotavirus-Adenovirus-Norovirus Combo Rapid Test (Feces)</tradeName>
    <deviceName>Rotavirus-Adenovirus-Norovirus Combo 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>MID-5032a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:09:05.806Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646HV001H4K2</udiDi>
    <basicUdiDi>B-697424646HV001H4K2</basicUdiDi>
    <tradeName>Hantavirus Rapid Test(WB/S/P)</tradeName>
    <deviceName>Hantavirus 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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HV-4012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:07:14.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646HV000H2JR</udiDi>
    <basicUdiDi>B-697424646HV000H2JR</basicUdiDi>
    <tradeName>Hantavirus IgG/IgM Rapid Test(WB/S/P)</tradeName>
    <deviceName>Hantavirus 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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HV-4022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:07:13.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646HSV002P26A</udiDi>
    <basicUdiDi>B-697424646HSV002P26A</basicUdiDi>
    <tradeName>Herpes simplex virus(HSV) IgG/IgM Rapid Test (Serum/Plasma)</tradeName>
    <deviceName>Herpes simplex virus(HSV) 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>HSV-3022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:07:09.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646HSV001NY8B</udiDi>
    <basicUdiDi>B-697424646HSV001NY8B</basicUdiDi>
    <tradeName>Herpes simplex virus(HSV) IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Herpes simplex virus(HSV) 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>HSV-4022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:07:09.612Z</lastUpdated>
  </row>
</eudamedExport>