<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>
  <row>
    <udiDi>D-OGGBDOA-1X5DN</udiDi>
    <basicUdiDi>B-OGGBDOA-1X5DN</basicUdiDi>
    <tradeName>One Step Multi-Drug Screen Test Cassette (Urine)</tradeName>
    <deviceName>One Step Multi-Drug Screen Test Cassette (Urine)</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>GBDOA-1X5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:12:15.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MTD-05-25tQN</udiDi>
    <basicUdiDi>B-MTD-05-25tQN</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName>Methadone (MTD) 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>W0102090110</emdnCode>
    <emdnDescription>METHADONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTD-05-25t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:18:18.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MTD-01-100tDL</udiDi>
    <basicUdiDi>B-MTD-01-100tDL</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName>Methadone (MTD) 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>W0102090110</emdnCode>
    <emdnDescription>METHADONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTD-01-100t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:18:17.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MTD-02-25tPM</udiDi>
    <basicUdiDi>B-MTD-02-25tPM</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName>Methadone (MTD) 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>W0102090110</emdnCode>
    <emdnDescription>METHADONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTD-02-25t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:18:14.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MS9500CL</udiDi>
    <basicUdiDi>B-MS9500CL</basicUdiDi>
    <tradeName>ClinMass®</tradeName>
    <deviceName>ClinMass® Add-on Set for Benzodiazepines in Serum / Plasma</deviceName>
    <manufacturerName>RECIPE Chemicals + Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000032553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090104</emdnCode>
    <emdnDescription>BENZODIAZEPINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MS9500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:16:36.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MOP-05-25tU7</udiDi>
    <basicUdiDi>B-MOP-05-25tU7</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName>Morphine (MOP) 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>W0102090112</emdnCode>
    <emdnDescription>MORPHINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MOP-05-25t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:09:02.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MOP-02-25tT6</udiDi>
    <basicUdiDi>B-MOP-02-25tT6</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName>Morphine (MOP) 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>W0102090112</emdnCode>
    <emdnDescription>MORPHINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MOP-02-25t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:09:00.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MOP-01-100tHP</udiDi>
    <basicUdiDi>B-MOP-01-100tHP</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName>Morphine (MOP) 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>W0102090112</emdnCode>
    <emdnDescription>MORPHINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MOP-01-100t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:08:58.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MET-05-25tPD</udiDi>
    <basicUdiDi>B-MET-05-25tPD</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName>Methamphetamine (MET) 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>W0102090110</emdnCode>
    <emdnDescription>METHADONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MET-05-25t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:06:26.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MET-01-100tBH</udiDi>
    <basicUdiDi>B-MET-01-100tBH</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName>Methamphetamine (MET) 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>W0102090110</emdnCode>
    <emdnDescription>METHADONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MET-01-100t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:06:26.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MET-02-25tNC</udiDi>
    <basicUdiDi>B-MET-02-25tNC</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName>Methamphetamine (MET) 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>W0102090110</emdnCode>
    <emdnDescription>METHADONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MET-02-25t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:06:09.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MDMA-05-25tHH</udiDi>
    <basicUdiDi>B-MDMA-05-25tHH</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName>Methylenedioxymethamphetamine (MDMA) 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>W0102090119</emdnCode>
    <emdnDescription>MDMA (ECSTASY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MDMA-05-25t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:03:32.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MDMA-02-25tGG</udiDi>
    <basicUdiDi>B-MDMA-02-25tGG</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName>Methylenedioxymethamphetamine (MDMA) 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>W0102090119</emdnCode>
    <emdnDescription>MDMA (ECSTASY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MDMA-02-25t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:03:32.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MDMA-01-100tBV</udiDi>
    <basicUdiDi>B-MDMA-01-100tBV</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName>Methylenedioxymethamphetamine (MDMA) 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>W0102090119</emdnCode>
    <emdnDescription>MDMA (ECSTASY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MDMA-01-100t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:03:29.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBXXX-1102J6</udiDi>
    <basicUdiDi>B-GBXXX-1102J6</basicUdiDi>
    <tradeName>Hair Multi-Drug Rapid Test Kit (ICA)</tradeName>
    <deviceName>Hair Multi-Drug Rapid Test Kit (ICA)</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>GBXXX-1102</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:22:26.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBXXX-105NM</udiDi>
    <basicUdiDi>B-GBXXX-105NM</basicUdiDi>
    <tradeName>One Step Drugs of Abuse Test Dip Card (Urine)</tradeName>
    <deviceName>One Step Drugs of Abuse Test Dip Card (Urine)</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>GBXXX-105</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:22:21.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBXXX-102NF</udiDi>
    <basicUdiDi>B-GBXXX-102NF</basicUdiDi>
    <tradeName>One Step Drugs of Abuse Test Cassette (Urine)</tradeName>
    <deviceName>One Step Drugs of Abuse Test Cassette (Urine)</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>GBXXX-102</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:22:20.260Z</lastUpdated>
  </row>
</eudamedExport>