<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-THC-05-25tMS</udiDi>
    <basicUdiDi>B-THC-05-25tMS</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName>Marijuana (THC) 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>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>THC-05-25t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:58:44.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-THC-02-25tLR</udiDi>
    <basicUdiDi>B-THC-02-25tLR</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName>Marijuana (THC) 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>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>THC-02-25t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:58:43.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-THC-01-100t8S</udiDi>
    <basicUdiDi>B-THC-01-100t8S</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName>Marijuana (THC) 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>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>THC-01-100t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:58:40.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TCA-05-25tGZ</udiDi>
    <basicUdiDi>B-TCA-05-25tGZ</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName>Tricyclic Antidepressants (TCA) 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>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TCA-05-25t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:55:24.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TCA-02-25tFY</udiDi>
    <basicUdiDi>B-TCA-02-25tFY</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName>Tricyclic Antidepressants (TCA) 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>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TCA-02-25t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:55:20.127Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TCA-01-100t2T</udiDi>
    <basicUdiDi>B-TCA-01-100t2T</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName>Tricyclic Antidepressants (TCA) 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>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TCA-01-100t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:55:19.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768014437</udiDi>
    <basicUdiDi>0405686901149VD</basicUdiDi>
    <tradeName>Emit II Plus Methaqualone 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>W0102090111</emdnCode>
    <emdnDescription>METHAQUALONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445474</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:45:02.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768014369</udiDi>
    <basicUdiDi>0405686901148VB</basicUdiDi>
    <tradeName>Emit II Plus Methadone 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>W0102090110</emdnCode>
    <emdnDescription>METHADONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445427</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:45:02.320Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768002212</udiDi>
    <basicUdiDi>0405686901149VD</basicUdiDi>
    <tradeName>Emit II Plus Methaqualone 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>W0102090111</emdnCode>
    <emdnDescription>METHAQUALONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445475</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:45:00.262Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768000157</udiDi>
    <basicUdiDi>0405686901148VB</basicUdiDi>
    <tradeName>Emit II Plus Methadone 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>W0102090110</emdnCode>
    <emdnDescription>METHADONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445428</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:45:00.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PCP-05-25tNA</udiDi>
    <basicUdiDi>B-PCP-05-25tNA</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName>Phencyclidine (PCP) 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>W0102090114</emdnCode>
    <emdnDescription>PHENCYCLIDINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCP-05-25t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T06:12:11.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PCP-02-25tM9</udiDi>
    <basicUdiDi>B-PCP-02-25tM9</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName>Phencyclidine (PCP) 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>W0102090114</emdnCode>
    <emdnDescription>PHENCYCLIDINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCP-02-25t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T06:12:10.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PCP-01-100t9Q</udiDi>
    <basicUdiDi>B-PCP-01-100t9Q</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName>Phencyclidine (PCP) 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>W0102090114</emdnCode>
    <emdnDescription>PHENCYCLIDINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCP-01-100t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T06:12:10.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OXY-05-25t9W</udiDi>
    <basicUdiDi>B-OXY-05-25t9W</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName>Oxycodone (OXY) 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>W0102090123</emdnCode>
    <emdnDescription>OXYCODINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OXY-05-25t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:15:44.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OXY-02-25t8V</udiDi>
    <basicUdiDi>B-OXY-02-25t8V</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName>Oxycodone (OXY) 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>W0102090123</emdnCode>
    <emdnDescription>OXYCODINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OXY-02-25t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:15:43.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OXY-01-100t2C</udiDi>
    <basicUdiDi>B-OXY-01-100t2C</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName>Oxycodone (OXY) 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>W0102090123</emdnCode>
    <emdnDescription>OXYCODINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OXY-01-100t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:15:42.527Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OPI-05-25tSK</udiDi>
    <basicUdiDi>B-OPI-05-25tSK</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName>Opiate (OPI) 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>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPI-05-25t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:15:15.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OPI-02-25tRJ</udiDi>
    <basicUdiDi>B-OPI-02-25tRJ</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName>Opiate (OPI) 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>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPI-02-25t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:15:14.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OPI-01-100tFH</udiDi>
    <basicUdiDi>B-OPI-01-100tFH</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName>Opiate (OPI) 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>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPI-01-100t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:15:10.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OGGBDSA-XXXXRX6H</udiDi>
    <basicUdiDi>B-OGGBDSA-XXXXRX6H</basicUdiDi>
    <tradeName>Oral Fluid Drug Test Square Cube</tradeName>
    <deviceName>Oral Fluid Drug Test Square Cube</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>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBDSA-XXXXRX</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:12:16.717Z</lastUpdated>
  </row>
</eudamedExport>