<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-697424646DEN005F2QN</udiDi>
    <basicUdiDi>B-697424646DEN005F2QN</basicUdiDi>
    <tradeName>Dengue IgG/IgM/NS1 Combo Rapid Test (WB/S/P)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DEN-4032</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:14.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646DEN006F4QX</udiDi>
    <basicUdiDi>B-697424646DEN006F4QX</basicUdiDi>
    <tradeName>Dengue IgG/IgM/NS1 Combo Rapid Test(Serum/Plasma)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DEN-3032</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:14.522Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646DIM000FKZ75</udiDi>
    <basicUdiDi>B-697424646DIM000FKZ75</basicUdiDi>
    <tradeName>D-Dimer FIA Test (Whole blood/Plasma)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIM-4012F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:14.506Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646DIM000FVTS</udiDi>
    <basicUdiDi>B-697424646DIM000FVTS</basicUdiDi>
    <tradeName>D-Dimer Rapid Test(Plasma)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIM-3012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:14.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646DIM001FL455</udiDi>
    <basicUdiDi>B-697424646DIM001FL455</basicUdiDi>
    <tradeName>D-Dimer FIA Test (Plasma)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIM-3012F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:14.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646DIM001FXU3</udiDi>
    <basicUdiDi>B-697424646DIM001FXU3</basicUdiDi>
    <tradeName>D-Dimer Rapid Test(Whole Blood/Plasma)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIM-4012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:14.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646DOAS001QHEF</udiDi>
    <basicUdiDi>B-697424646DOAS001QHEF</basicUdiDi>
    <tradeName>Multi drug Rapid Saliva Test(AMP/BZO/BAR/COC/MET/OPI/PCP/PPX/THC/OXY/KET/BUP/COT/EDDP/6-MAM/MDMA/MTD/TML/K2/FYL/TCA/CBD/ETG/MOR/MQL/LSD/ALC)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MDD-7**2/MDD-7**3/MDD-7**5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:14.429Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646EDDP000LV99</udiDi>
    <basicUdiDi>B-697424646EDDP000LV99</basicUdiDi>
    <tradeName>Methadone metabolite(EDDP) Rapid Test Kit(Urine)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EDDP-1011/EDDP-1012/EDDP-1014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:14.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646EDDP001LX9J</udiDi>
    <basicUdiDi>B-697424646EDDP001LX9J</basicUdiDi>
    <tradeName>Methadone metabolite(EDDP) Rapid Test(Urine)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EDDP-1011/EDDP-1012/EDDP-1014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:14.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646ETG000JRXW</udiDi>
    <basicUdiDi>B-697424646ETG000JRXW</basicUdiDi>
    <tradeName>Ethylglucoronide(ETG) Rapid Test Kit(Urine)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ETG-1011/ETG-1012/ETG-1014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:14.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646ETG001JTY7</udiDi>
    <basicUdiDi>B-697424646ETG001JTY7</basicUdiDi>
    <tradeName>Ethylglucoronide(ETG) Rapid Test (Urine)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ETG-1011/ETG-1012/ETG-1014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:14.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646ETO000LH2T</udiDi>
    <basicUdiDi>B-697424646ETO000LH2T</basicUdiDi>
    <tradeName>Cannabidiol(CBD)Rapid Test(Urine)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CBD-1011/CBD-1012/CBD-1014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:14.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646ETO001LK36</udiDi>
    <basicUdiDi>B-697424646ETO001LK36</basicUdiDi>
    <tradeName>Etomidate Rapid Test(Urine)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ETO-1011/ETO-1012/ETO-1014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:14.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646FCO000PKX7H</udiDi>
    <basicUdiDi>B-697424646FCO000PKX7H</basicUdiDi>
    <tradeName>Multi-Respiratory Virus Antigen Test(Swab) (Influenza A+B/ COVID-19)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCO-6032a/FCO-6032b</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:14.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646FCO6032PSYNG</udiDi>
    <basicUdiDi>B-697424646FCO6032PSYNG</basicUdiDi>
    <tradeName>Multi-Respiratory Virus Antigen Test Kit(Swab) (Influenza A+B/ COVID-19)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>NIC GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000033515</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCO-6032</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:14.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646FCRAh000836W</udiDi>
    <basicUdiDi>B-697424646FCRAh000836W</basicUdiDi>
    <tradeName>COVID-19/Flu/RSV/ADV/hMPV Antigen Combo Rapid Test</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCRAh-6062</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:14.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646FCRAhH000U46J</udiDi>
    <basicUdiDi>B-697424646FCRAhH000U46J</basicUdiDi>
    <tradeName>COVID-19/Flu/RSV/ADV/hMPV/HPIV Antigen Combo Rapid Test</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCRAhH-6082</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:14.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646FCRAM000PHFN4</udiDi>
    <basicUdiDi>B-697424646FCRAM000PHFN4</basicUdiDi>
    <tradeName>COVID-19/FluA&amp;B/RSV/ADV/MP Antigen Combo Rapid Test(Swab)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCRAM-6062</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:14.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646FCRAM6062HHMF</udiDi>
    <basicUdiDi>B-697424646FCRAM6062HHMF</basicUdiDi>
    <tradeName>COVID-19/Flu/RSV/ADV/MP Antigen Combo Rapid Test(Swab)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCRAM-6062</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:14.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646FER000FM66U</udiDi>
    <basicUdiDi>B-697424646FER000FM66U</basicUdiDi>
    <tradeName>Ferritin FIA Test (Serum/Plasma)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SPECIFIC PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FER-3012F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:44:14.208Z</lastUpdated>
  </row>
</eudamedExport>