<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06952804817305</udiDi>
    <basicUdiDi>B-06952804817305</basicUdiDi>
    <tradeName>Acetaminophen</tradeName>
    <deviceName>Acetaminophen 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>W0102090201</emdnCode>
    <emdnDescription>ACETAMINOPHENE (PARACETAMOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACE-U11, ACE-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:30:56.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804817282</udiDi>
    <basicUdiDi>B-06952804817282</basicUdiDi>
    <tradeName>Oxycodone Rapid Test</tradeName>
    <deviceName>Oxycodone 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>W0102090299</emdnCode>
    <emdnDescription>TOXICOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OXY-U11 OXY-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:30:52.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804817268</udiDi>
    <basicUdiDi>B-06952804817268</basicUdiDi>
    <tradeName>Ketamine Rapid Test</tradeName>
    <deviceName>Ketamine 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>W0102090299</emdnCode>
    <emdnDescription>TOXICOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KET-U11 KET-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:30:50.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804816841</udiDi>
    <basicUdiDi>B-06952804816841</basicUdiDi>
    <tradeName>Kratom (Mitragyna) Rapid Test</tradeName>
    <deviceName>Kratom (Mitragyna) 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>W0102090299</emdnCode>
    <emdnDescription>TOXICOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAR-U11 KAR-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:29:56.807Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293581726</udiDi>
    <basicUdiDi>697518250G127353J</basicUdiDi>
    <tradeName>Alcohol Panel Test Drugs of Abuse Test Kit</tradeName>
    <deviceName>Alcohol Panel Test Drugs of Abuse Test Kit</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090207</emdnCode>
    <emdnDescription>ETHANOL (ALCOHOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G12735</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:26:33.069Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293581580</udiDi>
    <basicUdiDi>697518250G1272239</basicUdiDi>
    <tradeName>Ethyl Glucuronide Panel Test Drugs of Abuse Test Kit</tradeName>
    <deviceName>Ethyl Glucuronide Panel Test Drugs of Abuse Test Kit</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090220</emdnCode>
    <emdnDescription>ETHYL GLUCURONIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G12722</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:26:02.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293581559</udiDi>
    <basicUdiDi>697518250G127193L</basicUdiDi>
    <tradeName>Tricyclic Antidepressants Panel Test Drugs of Abuse Test Kit</tradeName>
    <deviceName>Tricyclic Antidepressants Panel Test Drugs of Abuse Test Kit</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090215</emdnCode>
    <emdnDescription>TRICYCLIC ANTIDEPRESSANTS (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G12719</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:25:54.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339205117</udiDi>
    <basicUdiDi>B-06937339205117</basicUdiDi>
    <tradeName>VivaDiag Opium Test Kit (FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102090299</emdnCode>
    <emdnDescription>TOXICOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID76-09-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:53:49.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339205100</udiDi>
    <basicUdiDi>B-06937339205100</basicUdiDi>
    <tradeName>VivaDiag Synthetic Marijuana K3 Test Kit (FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102090299</emdnCode>
    <emdnDescription>TOXICOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID130-09-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:53:46.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595780673</udiDi>
    <basicUdiDi>B-06936595780673</basicUdiDi>
    <tradeName>Catecholamine Kit(LC-MS/MS)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102090204</emdnCode>
    <emdnDescription>CATECHOLAMINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZY3079P</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:59:39.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595750560</udiDi>
    <basicUdiDi>B-06936595750560</basicUdiDi>
    <tradeName>Ethanol Kit (Enzymatic Kinetic UV Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102090207</emdnCode>
    <emdnDescription>ETHANOL (ALCOHOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ435Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:54:45.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768023347</udiDi>
    <basicUdiDi>0405686901302UV</basicUdiDi>
    <tradeName>Emit® tox™ Salicylic Acid 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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090213</emdnCode>
    <emdnDescription>SALICYLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445394</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:24:16.201Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858724003476</udiDi>
    <basicUdiDi>0858724003ETG03633</basicUdiDi>
    <tradeName>ARK Ethyl Glucuronide Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090220</emdnCode>
    <emdnDescription>ETHYL GLUCURONIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5036-0001-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:17:23.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858724003483</udiDi>
    <basicUdiDi>0858724003ETG03633</basicUdiDi>
    <tradeName>ARK Ethyl Glucuronide Calibrator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090220</emdnCode>
    <emdnDescription>ETHYL GLUCURONIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5036-0002-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:17:23.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858724003490</udiDi>
    <basicUdiDi>0858724003ETG03633</basicUdiDi>
    <tradeName>ARK Ethyl Glucuronide Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090220</emdnCode>
    <emdnDescription>ETHYL GLUCURONIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5036-0003-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:17:23.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858724003506</udiDi>
    <basicUdiDi>0858724003ETG03633</basicUdiDi>
    <tradeName>ARK Ethyl Glucuronide Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090220</emdnCode>
    <emdnDescription>ETHYL GLUCURONIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5036-0003-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:17:23.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858724003513</udiDi>
    <basicUdiDi>0858724003ETG03633</basicUdiDi>
    <tradeName>ARK Ethyl Glucuronide Calibrator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090220</emdnCode>
    <emdnDescription>ETHYL GLUCURONIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5036-0002-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:17:23.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858724003520</udiDi>
    <basicUdiDi>0858724003ETG03633</basicUdiDi>
    <tradeName>ARK Ethyl Glucuronide Calibrator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090220</emdnCode>
    <emdnDescription>ETHYL GLUCURONIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5036-0002-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:17:23.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858724003599</udiDi>
    <basicUdiDi>0858724003ETG03633</basicUdiDi>
    <tradeName>ARK Ethyl Glucuronide Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090220</emdnCode>
    <emdnDescription>ETHYL GLUCURONIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5036-0001-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:17:22.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>05204309167487</udiDi>
    <basicUdiDi>B-05204309167487</basicUdiDi>
    <tradeName>ETHANOL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medicon Hellas SA</manufacturerName>
    <manufacturerSrn>GR-MF-000013625</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102090207</emdnCode>
    <emdnDescription>ETHANOL (ALCOHOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1415-1120</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-20T00:19:52.161Z</lastUpdated>
  </row>
</eudamedExport>