<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-GBALC-101aPZ</udiDi>
    <basicUdiDi>B-GBALC-101aPZ</basicUdiDi>
    <tradeName>Urine Alcohol Test Strip</tradeName>
    <deviceName>Urine Alcohol Test Strip</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBALC-101a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:15:19.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001963</udiDi>
    <basicUdiDi>0405686901158VE</basicUdiDi>
    <tradeName>Emit II Plus Phencyclidine Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090114</emdnCode>
    <emdnDescription>PHENCYCLIDINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445443</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:51.563Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001925</udiDi>
    <basicUdiDi>0405686901169VK</basicUdiDi>
    <tradeName>Emit II Plus Propoxyphene Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090115</emdnCode>
    <emdnDescription>PROPOXYPHENE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445435</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:43.999Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001826</udiDi>
    <basicUdiDi>0405686901152V2</basicUdiDi>
    <tradeName>Emit II Plus Opiate Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445417</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:42.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768014383</udiDi>
    <basicUdiDi>0405686901169VK</basicUdiDi>
    <tradeName>Emit II Plus Propoxyphene Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090115</emdnCode>
    <emdnDescription>PROPOXYPHENE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445434</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:38.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768014338</udiDi>
    <basicUdiDi>0405686901152V2</basicUdiDi>
    <tradeName>Emit II Plus Opiate Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445414</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:38.075Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768014406</udiDi>
    <basicUdiDi>0405686901158VE</basicUdiDi>
    <tradeName>Emit II Plus Phencyclidine Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090114</emdnCode>
    <emdnDescription>PHENCYCLIDINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445442</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:28.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FBFEN-102aSW</udiDi>
    <basicUdiDi>B-FBFEN-102aSW</basicUdiDi>
    <tradeName>Fentanyl Rapid Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName>Fentanyl Rapid Test Kit (Time-Resolved FIA)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090122</emdnCode>
    <emdnDescription>FENTANYL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FBFEN-102a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:17:34.885Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FBFEN-102aHGPE</udiDi>
    <basicUdiDi>B-FBFEN-102aHGPE</basicUdiDi>
    <tradeName>Fentanyl Rapid Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090122</emdnCode>
    <emdnDescription>FENTANYL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FBFEN-102a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:17:30.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EDDP-05-25tC7</udiDi>
    <basicUdiDi>B-EDDP-05-25tC7</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName>Methadone Metabolite (EDDP) One Step Test Kit (Colloidal Gold Method)</deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090120</emdnCode>
    <emdnDescription>EDDP SPECIFIC (METHADONE METABOLITES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EDDP-05-25t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:46:49.526Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EDDP-02-25tB6</udiDi>
    <basicUdiDi>B-EDDP-02-25tB6</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName>Methadone Metabolite (EDDP) One Step Test Kit (Colloidal Gold Method)</deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090120</emdnCode>
    <emdnDescription>EDDP SPECIFIC (METHADONE METABOLITES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EDDP-02-25t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:46:45.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EDDP-01-100t59</udiDi>
    <basicUdiDi>B-EDDP-01-100t59</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName>Methadone Metabolite (EDDP) One Step Test Kit (Colloidal Gold Method)</deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090120</emdnCode>
    <emdnDescription>EDDP SPECIFIC (METHADONE METABOLITES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EDDP-01-100t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:46:45.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DZOP-R102KX</udiDi>
    <basicUdiDi>B-DZOP-R102KX</basicUdiDi>
    <tradeName>ZOP Rapid Test Cassette</tradeName>
    <deviceName>ZOP Rapid Test Cassette</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>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>v</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:18:32.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DZAL-R102AV</udiDi>
    <basicUdiDi>B-DZAL-R102AV</basicUdiDi>
    <tradeName>ZAL Rapid Test Cassette</tradeName>
    <deviceName>ZAL Rapid Test Cassette</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>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DZAL-R102</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:18:31.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DTZD-R102HC</udiDi>
    <basicUdiDi>B-DTZD-R102HC</basicUdiDi>
    <tradeName>TZD Rapid Test Cassette</tradeName>
    <deviceName>TZD Rapid Test Cassette</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>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTZD-R102</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:18:20.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DTRO-R102HK</udiDi>
    <basicUdiDi>B-DTRO-R102HK</basicUdiDi>
    <tradeName>TRO Rapid Test Cassette</tradeName>
    <deviceName>TRO Rapid Test Cassette</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>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTRO-R102</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:18:19.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DTLD-R1029W</udiDi>
    <basicUdiDi>B-DTLD-R1029W</basicUdiDi>
    <tradeName>TLD Rapid Test Cassette</tradeName>
    <deviceName>TLD Rapid Test Cassette</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>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTLD-R102</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:18:18.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DTAP-R1028X</udiDi>
    <basicUdiDi>B-DTAP-R1028X</basicUdiDi>
    <tradeName>TAP Rapid Test Cassette</tradeName>
    <deviceName>TAP Rapid Test Cassette</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>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTAP-R102</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:18:14.551Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DSC-R102CM</udiDi>
    <basicUdiDi>B-DSC-R102CM</basicUdiDi>
    <tradeName>SCOP Rapid Test Cassette</tradeName>
    <deviceName>SCOP Rapid Test Cassette</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>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSC-R102</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:13:48.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DRPD-R102AU</udiDi>
    <basicUdiDi>B-DRPD-R102AU</basicUdiDi>
    <tradeName>Risperidone (RPD) Rapid Test Cassette</tradeName>
    <deviceName>Risperidone (RPD) Rapid Test Cassette</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>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRPD-R102</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:13:40.571Z</lastUpdated>
  </row>
</eudamedExport>