<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06976374752781</udiDi>
    <basicUdiDi>B-06976374752781</basicUdiDi>
    <tradeName>Methamphetamine Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Methamphetamine Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160501</emdnCode>
    <emdnDescription>AMPHETAMINES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests / kit（DR095-3）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:47:00.252Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976374752637</udiDi>
    <basicUdiDi>B-06976374752637</basicUdiDi>
    <tradeName>Amphetamine Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Amphetamine Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160501</emdnCode>
    <emdnDescription>AMPHETAMINES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests / kit（DR033-4）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:46:33.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202761244</udiDi>
    <basicUdiDi>B-06976202761244</basicUdiDi>
    <tradeName>Methamphetamine (MET) Rapid Test</tradeName>
    <deviceName>Methamphetamine (MET) Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160501</emdnCode>
    <emdnDescription>AMPHETAMINES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GDMET-A102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:33:30.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202761107</udiDi>
    <basicUdiDi>B-06976202761107</basicUdiDi>
    <tradeName>Amphetamine (AMP) Rapid Test</tradeName>
    <deviceName>Amphetamine (AMP) Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160501</emdnCode>
    <emdnDescription>AMPHETAMINES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GDAMP-B102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:32:54.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974912094027</udiDi>
    <basicUdiDi>B-06974912094027</basicUdiDi>
    <tradeName>Amphetamine (AMP) Rapid Test</tradeName>
    <deviceName>Amphetamine (AMP) Rapid Test</deviceName>
    <manufacturerName>Nexlab Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047094</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160501</emdnCode>
    <emdnDescription>AMPHETAMINES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DUAMP-C50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:03:05.272Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532670100225</udiDi>
    <basicUdiDi>B-03532670100225</basicUdiDi>
    <tradeName>DRUGCHECK+ AMP</tradeName>
    <deviceName>DRUGCHECK+ AMP</deviceName>
    <manufacturerName>BIOSYNEX Swiss SA</manufacturerName>
    <manufacturerSrn>CH-MF-000024717</manufacturerSrn>
    <authorisedRepresentativeName>BIOSYNEX</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000014076</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160501</emdnCode>
    <emdnDescription>AMPHETAMINES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1140002_SW</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:37:12.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643959132</udiDi>
    <basicUdiDi>59026439BRTDAMPU</basicUdiDi>
    <tradeName>05902643959132</tradeName>
    <deviceName>Amphetamine (AMP) 40 tests / DAM-102.</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160501</emdnCode>
    <emdnDescription>AMPHETAMINES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-DAM-102</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:01.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643958173</udiDi>
    <basicUdiDi>59026439BRT309JN</basicUdiDi>
    <tradeName>05902643958173</tradeName>
    <deviceName>Amfetamina (AMP) kasetki 40 szt.</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160501</emdnCode>
    <emdnDescription>AMPHETAMINES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-309-K040</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:26:55.978Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970581430876</udiDi>
    <basicUdiDi>B-06970581430876</basicUdiDi>
    <tradeName>Accu-Tell® AMP Cassette (Saliva)</tradeName>
    <deviceName>Accu-Tell® AMP Cassette</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160501</emdnCode>
    <emdnDescription>AMPHETAMINES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-DOA-B46</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:43:47.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970581430869</udiDi>
    <basicUdiDi>B-06970581430869</basicUdiDi>
    <tradeName>Accu-Tell® AMPCassette (Urine)</tradeName>
    <deviceName>Accu-Tell® AMP Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160501</emdnCode>
    <emdnDescription>AMPHETAMINES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-DOA-B24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:43:46.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970581430852</udiDi>
    <basicUdiDi>B-06970581430852</basicUdiDi>
    <tradeName>Accu-Tell® AMP Panel (Urine)</tradeName>
    <deviceName>Accu-Tell® AMP Panel (Urine)</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160501</emdnCode>
    <emdnDescription>AMPHETAMINES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-DOA-E24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:43:40.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970581430845</udiDi>
    <basicUdiDi>B-06970581430845</basicUdiDi>
    <tradeName>Accu-Tell® AMP Strip (Urine)</tradeName>
    <deviceName>Accu-Tell® AMP Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160501</emdnCode>
    <emdnDescription>AMPHETAMINES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-DOA-A24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:43:38.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952999405592</udiDi>
    <basicUdiDi>B-06952999405592</basicUdiDi>
    <tradeName>06952999405592</tradeName>
    <deviceName>ABON™ Urine Test Drug Screen Strip</deviceName>
    <manufacturerName>Abon Biopharm(Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000009171</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160501</emdnCode>
    <emdnDescription>AMPHETAMINES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DBA-101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T10:48:59.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952999405585</udiDi>
    <basicUdiDi>B-06952999405585</basicUdiDi>
    <tradeName>06952999405585</tradeName>
    <deviceName>ABON™ Urine Test Drug Screen Cassette</deviceName>
    <manufacturerName>Abon Biopharm(Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000009171</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160501</emdnCode>
    <emdnDescription>AMPHETAMINES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DAM-U102</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T10:48:58.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952999405578</udiDi>
    <basicUdiDi>B-06952999405578</basicUdiDi>
    <tradeName>06952999405578</tradeName>
    <deviceName>ABON™ Urine Test Drug Screen Cassette</deviceName>
    <manufacturerName>Abon Biopharm(Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000009171</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160501</emdnCode>
    <emdnDescription>AMPHETAMINES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DAM-102</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T10:48:52.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952999405561</udiDi>
    <basicUdiDi>B-06952999405561</basicUdiDi>
    <tradeName>06952999405561</tradeName>
    <deviceName>ABON™ Urine Test Drug Screen Strip</deviceName>
    <manufacturerName>Abon Biopharm(Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000009171</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160501</emdnCode>
    <emdnDescription>AMPHETAMINES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DAM-101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T10:48:51.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804814014</udiDi>
    <basicUdiDi>B-06952804814014</basicUdiDi>
    <tradeName>Amphetamine Rapid Test</tradeName>
    <deviceName>Amphetamine 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>W0102160501</emdnCode>
    <emdnDescription>AMPHETAMINES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMP-U11 AMP-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:28:01.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804803674</udiDi>
    <basicUdiDi>B-06952804803674</basicUdiDi>
    <tradeName>Amphetamine FIA</tradeName>
    <deviceName>Amphetamine 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>W0102160501</emdnCode>
    <emdnDescription>AMPHETAMINES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMP-H23F3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:25:23.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939663976022</udiDi>
    <basicUdiDi>B-06939663976022</basicUdiDi>
    <tradeName>One Step Amphetamine Rapid Test (Urine)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sejoy Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008447</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160501</emdnCode>
    <emdnDescription>AMPHETAMINES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Strip,Cassette,Panel,Cup</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:04:18.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339207302</udiDi>
    <basicUdiDi>B-06937339207302</basicUdiDi>
    <tradeName>Amphetamine (AMP) Rapid Test</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>W0102160501</emdnCode>
    <emdnDescription>AMPHETAMINES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VDAM-102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:54:42.113Z</lastUpdated>
  </row>
</eudamedExport>