<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-697424646MAL003GKUC</udiDi>
    <basicUdiDi>B-697424646MAL003GKUC</basicUdiDi>
    <tradeName>Malaria P.f./Pan Rapid Test  Kit(Whole Blood)</tradeName>
    <deviceName>Malaria P.f./Pan Rapid Test  Kit(Whole Blood)</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>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAL-4022b</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:08:09.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646MAL002GPUH</udiDi>
    <basicUdiDi>B-697424646MAL002GPUH</basicUdiDi>
    <tradeName>Malaria Pan Rapid Test (Whole Blood)</tradeName>
    <deviceName>Malaria Pan Rapid Test (Whole Blood)</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>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAL-4011c/MAL-4012c</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:08:07.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646MAL002GKU7</udiDi>
    <basicUdiDi>B-697424646MAL002GKU7</basicUdiDi>
    <tradeName>Malaria P.f./P.v. Rapid Test  Kit(Whole Blood)</tradeName>
    <deviceName>Malaria P.f./P.v. Rapid Test  Kit(Whole Blood)</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>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAL-4022a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:08:05.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646MAL001GMU6</udiDi>
    <basicUdiDi>B-697424646MAL001GMU6</basicUdiDi>
    <tradeName>Malaria  P.v. Rapid Test (Whole Blood)</tradeName>
    <deviceName>Malaria  P.v. Rapid Test (Whole Blood)</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>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAL-4011b/MAL-4012b</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:08:03.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646MAL001GKU2</udiDi>
    <basicUdiDi>B-697424646MAL001GKU2</basicUdiDi>
    <tradeName>Malaria P.f. Rapid Test  Kit(Whole Blood)</tradeName>
    <deviceName>Malaria P.f. Rapid Test  Kit(Whole Blood)</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>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAL-4011/MAL-4012a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:08:01.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646MAL000GKTV</udiDi>
    <basicUdiDi>B-697424646MAL000GKTV</basicUdiDi>
    <tradeName>Malaria  P.f. Rapid Test (Whole Blood)</tradeName>
    <deviceName>Malaria  P.f. Rapid Test (Whole Blood)</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>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAL-4011a/MAL-4012a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:07:59.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646LEI002GZVF</udiDi>
    <basicUdiDi>B-697424646LEI002GZVF</basicUdiDi>
    <tradeName>Leishmaniasis IgG/IgM Rapid Test (Serum/Plasma)</tradeName>
    <deviceName>Leishmaniasis 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>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LEI-3021/LEI-3022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:07:50.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646LEI001GXV6</udiDi>
    <basicUdiDi>B-697424646LEI001GXV6</basicUdiDi>
    <tradeName>Leishmaniasis IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Leishmaniasis 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>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LEI-4021/LEI-4022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:07:33.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646LEI000GVUV</udiDi>
    <basicUdiDi>B-697424646LEI000GVUV</basicUdiDi>
    <tradeName>Leishmaniasis Rapid Test (Whole Blood/serum/plasma)</tradeName>
    <deviceName>Leishmaniasis 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>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LEI-4011/LEI-4012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:07:32.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646CHA002CMM9</udiDi>
    <basicUdiDi>B-697424646CHA002CMM9</basicUdiDi>
    <tradeName>Chagas Rapid Test (Serum/Plasma)</tradeName>
    <deviceName>Chagas 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>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHA-3011/CHA-3012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:03:38.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646CHA001CKLY</udiDi>
    <basicUdiDi>B-697424646CHA001CKLY</basicUdiDi>
    <tradeName>Chagas Rapid Test (WB/S/P)</tradeName>
    <deviceName>Chagas 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>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHA-4011/CHA-4012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:03:38.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646CHA000CHLM</udiDi>
    <basicUdiDi>B-697424646CHA000CHLM</basicUdiDi>
    <tradeName>Chagas Rapid Test (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Chagas 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>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHA-4011/CHA-4012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:03:37.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712009038Z</udiDi>
    <basicUdiDi>B-69717712009038Z</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Malaria Rapid Test</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAL-W21- FV（25PCS）</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:57:08.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>6970277510023AXW</udiDi>
    <basicUdiDi>B-6970277510023AXW</basicUdiDi>
    <tradeName>6970277510023AXW</tradeName>
    <deviceName>Malaria P.f./P.v. Rapid Test Dipstick</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>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMPV-401</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:50:32.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757991703QP</udiDi>
    <basicUdiDi>B-693757991703QP</basicUdiDi>
    <tradeName>Diagnostic Kit for Pan/ P.falciparum Antigen (Colloidal Gold)</tradeName>
    <deviceName>Diagnostic Kit for Pan/ P.falciparum Antigen (Colloidal Gold)</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>MA-Pan/Pf 50170301 MA-Pan/Pf 25170302</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:49:16.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757991702QM</udiDi>
    <basicUdiDi>B-693757991702QM</basicUdiDi>
    <tradeName>Diagnostic Kit for P.falciparum Antigen （Colloidal Gold)</tradeName>
    <deviceName>Diagnostic Kit for P.falciparum Antigen （Colloidal Gold)</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>MA-Pf 50170101 MA-Pf 25170102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:49:14.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-693757991701QK</udiDi>
    <basicUdiDi>B-693757991701QK</basicUdiDi>
    <tradeName>Diagnostic Kit for P.falciparum /P.vivax Antigen(Colloidal Gold)</tradeName>
    <deviceName>Diagnostic Kit for P.falciparum /P.vivax Antigen(Colloidal Gold)</deviceName>
    <manufacturerName>Nantong EgensBiotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021561</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>MA-Pf/Pv 50170201 MA-Pf/Pv 25170202</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:49:12.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230182723590</udiDi>
    <basicUdiDi>B-62230182723590</basicUdiDi>
    <tradeName>Malaria Antigen Test (Whole Blood) For Plasmodium falciparum &amp; vivax</tradeName>
    <deviceName>Malaria Antigen Test (Whole Blood) For Plasmodium falciparum &amp; vivax</deviceName>
    <manufacturerName>Kalians Corporation</manufacturerName>
    <manufacturerSrn>EG-MF-000050142</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-796 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:38:31.125Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440212584</udiDi>
    <basicUdiDi>84354402IDXGASTROB_NE77</basicUdiDi>
    <tradeName>CerTest Crypto+Giardia+Entamoeba</tradeName>
    <deviceName>CerTest Crypto+Giardia+Entamoeba</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>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NE872001V</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:19:46.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440211914</udiDi>
    <basicUdiDi>84354402IDXGASTROB_NW8B</basicUdiDi>
    <tradeName>CerTest Crypto+Giardia</tradeName>
    <deviceName>CerTest Crypto+Giardia</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>W0105090499</emdnCode>
    <emdnDescription>PARASITES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NW882001V</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:19:44.075Z</lastUpdated>
  </row>
</eudamedExport>