<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-DOP-102S9</udiDi>
    <basicUdiDi>B-DOP-102S9</basicUdiDi>
    <tradeName>D-DOP-102S9</tradeName>
    <deviceName>Opiates (OPI) Rapid Test Cassette (Urine)</deviceName>
    <manufacturerName>CITEST DIAGNOSTICS INC</manufacturerName>
    <manufacturerSrn>CA-MF-000022516</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160508</emdnCode>
    <emdnDescription>OPIATES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DOP-102</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:48:26.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A062D5</udiDi>
    <basicUdiDi>B-A062D5</basicUdiDi>
    <tradeName>D-A062D5</tradeName>
    <deviceName>INDICAID™ Fentanyl Rapid 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>W0102160508</emdnCode>
    <emdnDescription>OPIATES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Fentanyl Rapid Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:43:12.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A059DG</udiDi>
    <basicUdiDi>B-A059DG</basicUdiDi>
    <tradeName>D-A059DG</tradeName>
    <deviceName>INDICAID™ Morphine Rapid 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>W0102160508</emdnCode>
    <emdnDescription>OPIATES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Morphine Rapid Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:43:09.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646OPI001MX5F</udiDi>
    <basicUdiDi>B-697424646OPI001MX5F</basicUdiDi>
    <tradeName>Opiate(OPI) Rapid Test(Urine)</tradeName>
    <deviceName>Opiate(OPI) Rapid Test(Urine)</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>W0102160508</emdnCode>
    <emdnDescription>OPIATES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPI-1011/OPI-1012/OPI-1014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:14:01.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646OPI000MV56</udiDi>
    <basicUdiDi>B-697424646OPI000MV56</basicUdiDi>
    <tradeName>Opiate(OPI) Rapid Test Kit(Urine)</tradeName>
    <deviceName>Opiate(OPI) Rapid Test Kit(Urine)</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>W0102160508</emdnCode>
    <emdnDescription>OPIATES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPI-1011/OPI-1012/OPI-1014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:13:59.974Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646MOR001NR74</udiDi>
    <basicUdiDi>B-697424646MOR001NR74</basicUdiDi>
    <tradeName>Morphine Heroin(MOR) Rapid Test (Urine)</tradeName>
    <deviceName>Morphine Heroin(MOR) Rapid Test (Urine)</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>W0102160508</emdnCode>
    <emdnDescription>OPIATES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MOP-1011/MOP-1012/MOP-1014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:09:37.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646MOR000NP6T</udiDi>
    <basicUdiDi>B-697424646MOR000NP6T</basicUdiDi>
    <tradeName>Morphine Heroin(MOR) Rapid Test Kit(Urine)</tradeName>
    <deviceName>Morphine Heroin(MOR) Rapid Test Kit(Urine)</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>W0102160508</emdnCode>
    <emdnDescription>OPIATES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MOR-1011/MOR-1012/MOR-1014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:09:33.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-69717712013208A</udiDi>
    <basicUdiDi>B-69717712013208A</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Opiates (OPI) Rapid Test (Urine)</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>W0102160508</emdnCode>
    <emdnDescription>OPIATES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPI-U11（25PCS）</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:58:17.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6909620WHDUSOPINAVJ</udiDi>
    <basicUdiDi>B-6909620WHDUSOPINAVJ</basicUdiDi>
    <tradeName>One-Step Drug of Abuse Test -Opiates (OPI)</tradeName>
    <deviceName>Drugs of Abuse Tests (Opiate)</deviceName>
    <manufacturerName>W.H.P.M. Bioresearch &amp; Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003007</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160508</emdnCode>
    <emdnDescription>OPIATES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WH-DU-S0x1001; WH-DU-S0x1002; WH-DU-S0x1003; WH-DU-S0x1004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:47:37.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-nvm-620150SG</udiDi>
    <basicUdiDi>B-nvm-620150SG</basicUdiDi>
    <tradeName>nal von minden Drug-Screen® BUP 10 Test</tradeName>
    <deviceName>BUP 10 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>W0102160508</emdnCode>
    <emdnDescription>OPIATES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>620150</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:29:01.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-nvm-620035SF</udiDi>
    <basicUdiDi>B-nvm-620035SF</basicUdiDi>
    <tradeName>nal von minden Drug-Screen® MOR/OPI 300 Test</tradeName>
    <deviceName>MOR/OPI 300 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>W0102160508</emdnCode>
    <emdnDescription>OPIATES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>620035</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:28:50.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-nvm-102071BA6X</udiDi>
    <basicUdiDi>B-nvm-102071BA6X</basicUdiDi>
    <tradeName>nal von minden Drug-Screen® TIL 300 Test barcoded</tradeName>
    <deviceName>TIL 300 Test barcoded</deviceName>
    <manufacturerName>nal von minden GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013321</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160508</emdnCode>
    <emdnDescription>OPIATES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102071BA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:24:08.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-nvm-102032PY</udiDi>
    <basicUdiDi>B-nvm-102032PY</basicUdiDi>
    <tradeName>nal von minden Drug-Screen® OXY 100 Test</tradeName>
    <deviceName>OXY 100 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>W0102160508</emdnCode>
    <emdnDescription>OPIATES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102032</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:23:56.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-nvm-102029QB</udiDi>
    <basicUdiDi>B-nvm-102029QB</basicUdiDi>
    <tradeName>nal von minden Drug-Screen® FYL10 Test</tradeName>
    <deviceName>FYL10 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>W0102160508</emdnCode>
    <emdnDescription>OPIATES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102029</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:23:51.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-nvm-102009Q5</udiDi>
    <basicUdiDi>B-nvm-102009Q5</basicUdiDi>
    <tradeName>nal von minden Drug-Screen® MOR/OPI 300 Test</tradeName>
    <deviceName>MOR/OPI 300 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>W0102160508</emdnCode>
    <emdnDescription>OPIATES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102009</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:21:12.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-nvm-102004PT</udiDi>
    <basicUdiDi>B-nvm-102004PT</basicUdiDi>
    <tradeName>nal von minden Drug-Screen® BUP 10 Test</tradeName>
    <deviceName>BUP 10 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>W0102160508</emdnCode>
    <emdnDescription>OPIATES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:21:05.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-nvm-101032PR</udiDi>
    <basicUdiDi>B-nvm-101032PR</basicUdiDi>
    <tradeName>nal von minden Drug-Screen® OXY 100 Test</tradeName>
    <deviceName>OXY 100 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>W0102160508</emdnCode>
    <emdnDescription>OPIATES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101032</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:20:49.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-nvm-101029Q4</udiDi>
    <basicUdiDi>B-nvm-101029Q4</basicUdiDi>
    <tradeName>nal von minden Drug-Screen® FYL 10 Test</tradeName>
    <deviceName>FYL 10 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>W0102160508</emdnCode>
    <emdnDescription>OPIATES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101029</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:20:27.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-nvm-101028Q2</udiDi>
    <basicUdiDi>B-nvm-101028Q2</basicUdiDi>
    <tradeName>nal von minden Drug-Screen® TML 100 Test</tradeName>
    <deviceName>TML 100 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>W0102160508</emdnCode>
    <emdnDescription>OPIATES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101028</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:20:26.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-nvm-101009PW</udiDi>
    <basicUdiDi>B-nvm-101009PW</basicUdiDi>
    <tradeName>nal von minden Drug-Screen® MOR/OPI 300 Test</tradeName>
    <deviceName>MOR/OPI 300 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>W0102160508</emdnCode>
    <emdnDescription>OPIATES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101009</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:20:14.543Z</lastUpdated>
  </row>
</eudamedExport>