<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-VDMC-1108-002MA</udiDi>
    <basicUdiDi>B-VDMC-1108-002MA</basicUdiDi>
    <tradeName>Multi-Drugs Rapid Test 1-Step Cup</tradeName>
    <deviceName>Multi-Drugs Rapid Test 1-Step Cup</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>IVDD</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VDMC-1108-002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:16:05.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VDKC-1108-001KA</udiDi>
    <basicUdiDi>B-VDKC-1108-001KA</basicUdiDi>
    <tradeName>Multi-Drugs Rapid Test Key Cup</tradeName>
    <deviceName>Multi-Drugs Rapid Test Key Cup</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>IVDD</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VDKC-1108-001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:15:58.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SOMA-A01aFT</udiDi>
    <basicUdiDi>B-SOMA-A01aFT</basicUdiDi>
    <tradeName>SOMA One Step Carisoprodol Test</tradeName>
    <deviceName>SOMA One Step Carisoprodol Test</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SOMA-A01a, SOMA-A01b</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:46:27.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MTO-4-AZS</udiDi>
    <basicUdiDi>B-MTO-4-AZS</basicUdiDi>
    <tradeName>Metomidate (MTO) Rapid Test Panel</tradeName>
    <deviceName>Metomidate (MTO) Rapid Test Panel</deviceName>
    <manufacturerName>ACtest Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049724</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTO-4-A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:18:25.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MTO-2-AZG</udiDi>
    <basicUdiDi>B-MTO-2-AZG</basicUdiDi>
    <tradeName>Metomidate (MTO) Rapid Test Cassette</tradeName>
    <deviceName>Metomidate (MTO) Rapid Test Cassette</deviceName>
    <manufacturerName>ACtest Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049724</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTO-2-A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:18:23.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MTO-1-AZB</udiDi>
    <basicUdiDi>B-MTO-1-AZB</basicUdiDi>
    <tradeName>Metomidate (MTO) Rapid Test Dipstick</tradeName>
    <deviceName>Metomidate (MTO) Rapid Test Dipstick</deviceName>
    <manufacturerName>ACtest Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049724</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTO-1-A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:18:21.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MD-W42W415TT</udiDi>
    <basicUdiDi>B-MD-W42W415TT</basicUdiDi>
    <tradeName>D-MD-W42W415TT</tradeName>
    <deviceName>Multi-drug Single-line Whole Blood Test Device</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>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD-W42~MD-W415</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:03:12.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MD-S32S316QB</udiDi>
    <basicUdiDi>B-MD-S32S316QB</basicUdiDi>
    <tradeName>D-MD-S32S316QB</tradeName>
    <deviceName>Multi-drug Saliva Test Stick</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>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD-S32~MD-S316</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:03:08.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MD-S32S312Q3</udiDi>
    <basicUdiDi>B-MD-S32S312Q3</basicUdiDi>
    <tradeName>D-MD-S32S312Q3</tradeName>
    <deviceName>Multi-drug Saliva Test Kit</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>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD-S32~MD-S312</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:03:07.729Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MD-U42U415SB</udiDi>
    <basicUdiDi>B-MD-U42U415SB</basicUdiDi>
    <tradeName>D-MD-U42U415SB</tradeName>
    <deviceName>Multi-drug Single-line Urine Test Device</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>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD-U42~MD-U415</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:03:06.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MD-S42S415QT</udiDi>
    <basicUdiDi>B-MD-S42S415QT</basicUdiDi>
    <tradeName>D-MD-S42S415QT</tradeName>
    <deviceName>Multi-drug Single-line Saliva Test Device</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>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD-S42~MD-S415</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:03:06.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-LSD-A01aGK</udiDi>
    <basicUdiDi>B-LSD-A01aGK</basicUdiDi>
    <tradeName>LSD One Step Lysergic acid diethylamide Test</tradeName>
    <deviceName>LSD One Step Lysergic acid diethylamide Test</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LSD-A01a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:53:14.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBXXX-1102HGN3</udiDi>
    <basicUdiDi>B-GBXXX-1102HGN3</basicUdiDi>
    <tradeName>Drugs of Abuse Rapid Test Cassette (Hair)</tradeName>
    <deviceName>Drugs of Abuse Rapid Test Cassette (Hair)</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>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBXXX-1102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:22:25.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBXXX-105HGKK</udiDi>
    <basicUdiDi>B-GBXXX-105HGKK</basicUdiDi>
    <tradeName>One Step Drugs of Abuse Test Dip Card (Urine)</tradeName>
    <deviceName>One Step Drugs of Abuse Test Dip Card (Urine)</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>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBXXX-105</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:22:21.069Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBXXX-102HGK4</udiDi>
    <basicUdiDi>B-GBXXX-102HGK4</basicUdiDi>
    <tradeName>One Step Drugs of Abuse Test Cassette (Urine)</tradeName>
    <deviceName>One Step Drugs of Abuse Test Cassette (Urine)</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>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBXXX-102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:22:19.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBXXX-101HGJX</udiDi>
    <basicUdiDi>B-GBXXX-101HGJX</basicUdiDi>
    <tradeName>One Step Drugs of Abuse Test Strip (Urine)</tradeName>
    <deviceName>One Step Drugs of Abuse Test Strip (Urine)</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>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBXXX-101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:22:14.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBDUAVC-1X6HGVE</udiDi>
    <basicUdiDi>B-GBDUAVC-1X6HGVE</basicUdiDi>
    <tradeName>One Step Multi-Drug Screen Test Vacuum Cup (Urine)</tradeName>
    <deviceName>One Step Multi-Drug Screen Test Vacuum Cup (Urine)</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>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBDUAVC-1X6</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:17:16.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBDUAVC-1X6-ALCHGYL</udiDi>
    <basicUdiDi>B-GBDUAVC-1X6-ALCHGYL</basicUdiDi>
    <tradeName>One Step Multi-Drug Screen Test Vacuum Cup (Urine)</tradeName>
    <deviceName>One Step Multi-Drug Screen Test Vacuum Cup (Urine)</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>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBDUAVC-1X6-ALC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:17:11.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBDUA-1X6HGXS</udiDi>
    <basicUdiDi>B-GBDUA-1X6HGXS</basicUdiDi>
    <tradeName>One Step Multi-Drug Screen Test Cup (Urine)</tradeName>
    <deviceName>One Step Multi-Drug Screen Test Cup (Urine)</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>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBDUA-1X6</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:16:56.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBDUA-1X6-ALCHGRM</udiDi>
    <basicUdiDi>B-GBDUA-1X6-ALCHGRM</basicUdiDi>
    <tradeName>One Step Multi-Drug Screen Test Cup (Urine)</tradeName>
    <deviceName>One Step Multi-Drug Screen Test Cup (Urine)</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>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBDUA-1X6-ALC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:16:54.790Z</lastUpdated>
  </row>
</eudamedExport>