<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06936020140416</udiDi>
    <basicUdiDi>69360201528X</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName>Multi-Drug One Step Test Kit (Colloidal Gold Method) (BZO/BAR/MDMA/MTD/OXY)</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 Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M90-05-25t</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:44.191Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936020140386</udiDi>
    <basicUdiDi>69360201118H</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName>Multi-Drug One Step Test Kit (Colloidal Gold Method)(COC/AMP/MET/MOP/THC)</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 Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M61-05-25t</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:43.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804817619</udiDi>
    <basicUdiDi>B-06952804817619</basicUdiDi>
    <tradeName>Carfentanyl Rapid Test</tradeName>
    <deviceName>Carfentanyl Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFYL-U11 CFYL-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:31:37.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804817558</udiDi>
    <basicUdiDi>B-06952804817558</basicUdiDi>
    <tradeName>Hydromorphone Rapid Test</tradeName>
    <deviceName>Hydromorphone Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090112</emdnCode>
    <emdnDescription>MORPHINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HMO-U11 HMO-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:31:30.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804817534</udiDi>
    <basicUdiDi>B-06952804817534</basicUdiDi>
    <tradeName>Tilidin Rapid Test</tradeName>
    <deviceName>Tilidin Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TLD-U11 TLD-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:31:27.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804817497</udiDi>
    <basicUdiDi>B-06952804817497</basicUdiDi>
    <tradeName>Zaleplon Rapid Test</tradeName>
    <deviceName>Zaleplon Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZAL-U11 ZAL-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:31:21.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804817428</udiDi>
    <basicUdiDi>B-06952804817428</basicUdiDi>
    <tradeName>7-Amino clonazepam Rapid Test</tradeName>
    <deviceName>7-Amino clonazepam Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090104</emdnCode>
    <emdnDescription>BENZODIAZEPINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7-ACL-U11 7-ACL-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:31:10.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804817404</udiDi>
    <basicUdiDi>B-06952804817404</basicUdiDi>
    <tradeName>Clonazepam Rapid Test</tradeName>
    <deviceName>Clonazepam Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090104</emdnCode>
    <emdnDescription>BENZODIAZEPINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLO-U11 CLO-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:31:09.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804817329</udiDi>
    <basicUdiDi>B-06952804817329</basicUdiDi>
    <tradeName>6-Monoacetylmorphine</tradeName>
    <deviceName>6-Monoacetylmorphine</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090112</emdnCode>
    <emdnDescription>MORPHINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAM-U11 MAM-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:31:00.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804817244</udiDi>
    <basicUdiDi>B-06952804817244</basicUdiDi>
    <tradeName>Fentanyl Rapid Test</tradeName>
    <deviceName>Fentanyl Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FYL-U11 FYL-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:30:49.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804817206</udiDi>
    <basicUdiDi>B-06952804817206</basicUdiDi>
    <tradeName>Buprenorphine Rapid Test</tradeName>
    <deviceName>Buprenorphine Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090117</emdnCode>
    <emdnDescription>BUPRENORPHINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BUP-U11 BUP-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:30:43.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804817183</udiDi>
    <basicUdiDi>B-06952804817183</basicUdiDi>
    <tradeName>Propoxyphene Rapid Test</tradeName>
    <deviceName>Propoxyphene Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090115</emdnCode>
    <emdnDescription>PROPOXYPHENE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PPX-U11, PPX-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:30:40.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804817169</udiDi>
    <basicUdiDi>B-06952804817169</basicUdiDi>
    <tradeName>Methaqualone Rapid Test</tradeName>
    <deviceName>Methaqualone Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090111</emdnCode>
    <emdnDescription>METHAQUALONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MQL-U11 MQL-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:30:39.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804817107</udiDi>
    <basicUdiDi>B-06952804817107</basicUdiDi>
    <tradeName>Meperidine Rapid Test</tradeName>
    <deviceName>Meperidine Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPRD-U11, MPRD-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:30:30.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804817022</udiDi>
    <basicUdiDi>B-06952804817022</basicUdiDi>
    <tradeName>Cotinine Rapid Test</tradeName>
    <deviceName>Cotinine Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090108</emdnCode>
    <emdnDescription>COTININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COT-U11, COT-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:30:19.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804814571</udiDi>
    <basicUdiDi>B-06952804814571</basicUdiDi>
    <tradeName>Pregabalin Rapid Test</tradeName>
    <deviceName>Pregabalin Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090112</emdnCode>
    <emdnDescription>MORPHINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PGB-U11 PGB-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:28:24.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804814496</udiDi>
    <basicUdiDi>B-06952804814496</basicUdiDi>
    <tradeName>Tramadol Rapid Test</tradeName>
    <deviceName>Tramadol Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090107</emdnCode>
    <emdnDescription>CODEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TML-U11 TML-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:28:20.473Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804814335</udiDi>
    <basicUdiDi>B-06952804814335</basicUdiDi>
    <tradeName>Morphine Rapid Test</tradeName>
    <deviceName>Morphine Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090112</emdnCode>
    <emdnDescription>MORPHINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MOR-U11, MOR-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:28:13.382Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804803681</udiDi>
    <basicUdiDi>B-06952804803681</basicUdiDi>
    <tradeName>Fentanyl FIA</tradeName>
    <deviceName>Fentanyl FIA</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FYL-U23F3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:25:23.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804803643</udiDi>
    <basicUdiDi>B-06952804803643</basicUdiDi>
    <tradeName>MDMA FIA</tradeName>
    <deviceName>MDMA FIA</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MDMA-H23F3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:25:21.175Z</lastUpdated>
  </row>
</eudamedExport>