<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-GBK2-102bHG5N</udiDi>
    <basicUdiDi>B-GBK2-102bHG5N</basicUdiDi>
    <tradeName>One Step K2 Test Cassette (Urine)</tradeName>
    <deviceName>One Step K2 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>W0102160505</emdnCode>
    <emdnDescription>CANNABINOIDS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBK2-102b</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:17:50.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBK2-102aHG5H</udiDi>
    <basicUdiDi>B-GBK2-102aHG5H</basicUdiDi>
    <tradeName>One Step K2 Test Cassette (Urine)</tradeName>
    <deviceName>One Step K2 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>W0102160505</emdnCode>
    <emdnDescription>CANNABINOIDS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBK2-102a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:17:47.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBK2-101bHG5F</udiDi>
    <basicUdiDi>B-GBK2-101bHG5F</basicUdiDi>
    <tradeName>One Step K2 Test Strip (Urine)</tradeName>
    <deviceName>One Step K2 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>W0102160505</emdnCode>
    <emdnDescription>CANNABINOIDS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBK2-101b</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:17:46.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBK2-101aHG5A</udiDi>
    <basicUdiDi>B-GBK2-101aHG5A</basicUdiDi>
    <tradeName>One Step K2 Test Strip (Urine)</tradeName>
    <deviceName>One Step K2 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>W0102160505</emdnCode>
    <emdnDescription>CANNABINOIDS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBK2-101a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:17:42.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DTHC100VZ</udiDi>
    <basicUdiDi>B-DTHC100VZ</basicUdiDi>
    <tradeName>Marijuana (THC) Rapid Test</tradeName>
    <deviceName>Marijuana (THC) Rapid Test</deviceName>
    <manufacturerName>Hangzhou Clongene Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030069</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160505</emdnCode>
    <emdnDescription>CANNABINOIDS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTHC1001,STHC1002,DTHC1004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:18:16.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DCNB-R102XY</udiDi>
    <basicUdiDi>B-DCNB-R102XY</basicUdiDi>
    <tradeName>CNB Rapid Test Cassette</tradeName>
    <deviceName>CNB Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160505</emdnCode>
    <emdnDescription>CANNABINOIDS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DCNB-R102</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:17:23.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684595032718</udiDi>
    <basicUdiDi>B-08684595032718</basicUdiDi>
    <tradeName>RapidFor™ UR-144 Rapid Test Kit (Urine)</tradeName>
    <deviceName>UR-144 Rapid Test Kit (Urine)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160505</emdnCode>
    <emdnDescription>CANNABINOIDS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VDOA33</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:15:35.807Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684595032701</udiDi>
    <basicUdiDi>B-08684595032701</basicUdiDi>
    <tradeName>RapidFor™ AB-PINACA Rapid Test Kit (Urine)</tradeName>
    <deviceName>AB-PINACA Rapid Test Kit (Urine)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160505</emdnCode>
    <emdnDescription>CANNABINOIDS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VDOA32</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:15:31.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684595032541</udiDi>
    <basicUdiDi>B-08684595032541</basicUdiDi>
    <tradeName>DrugFor™ UR-144 Rapid Test Kit (Urine)</tradeName>
    <deviceName>UR-144 Rapid Test Kit (Urine)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160505</emdnCode>
    <emdnDescription>CANNABINOIDS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VDDOA33</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:15:06.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684595032534</udiDi>
    <basicUdiDi>B-08684595032534</basicUdiDi>
    <tradeName>DrugFor™ AB-PINACA Rapid Test Kit (Urine)</tradeName>
    <deviceName>AB-PINACA Rapid Test Kit (Urine)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160505</emdnCode>
    <emdnDescription>CANNABINOIDS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VDDOA32</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:15:05.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684595030318</udiDi>
    <basicUdiDi>B-08684595030318</basicUdiDi>
    <tradeName>RapidFor™ THC Detection Kit (Saliva) (FIA)</tradeName>
    <deviceName>THC Detection Kit (Saliva) (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160505</emdnCode>
    <emdnDescription>CANNABINOIDS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO96</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:13:35.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684595030264</udiDi>
    <basicUdiDi>B-08684595030264</basicUdiDi>
    <tradeName>RapidFor™ UR-144 Detection Kit (Urine) (FIA)</tradeName>
    <deviceName>UR-144 Detection Kit (Urine) (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160505</emdnCode>
    <emdnDescription>CANNABINOIDS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO91</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:13:29.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548251657</udiDi>
    <basicUdiDi>B-08683548251657</basicUdiDi>
    <tradeName>DrugFor™ Synthetic Cannabinoid (K2) Rapid Test Kit (Urine)</tradeName>
    <deviceName>Synthetic Cannabinoid (K2) Rapid Test Kit (Urine)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160505</emdnCode>
    <emdnDescription>CANNABINOIDS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VDDOA17</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:12:54.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548251367</udiDi>
    <basicUdiDi>B-08683548251367</basicUdiDi>
    <tradeName>RapidFor™ Synthetic Cannabinoid (K2) Rapid Test Kit (Urine)</tradeName>
    <deviceName>Synthetic Cannabinoid (K2) Rapid Test Kit (Urine)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160505</emdnCode>
    <emdnDescription>CANNABINOIDS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VDOA17</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:11:56.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683347941254</udiDi>
    <basicUdiDi>B-08683347941254</basicUdiDi>
    <tradeName>RapidFor™ K2 Rapid Test Kit</tradeName>
    <deviceName>RapidFor™ K2 Rapid Test Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160505</emdnCode>
    <emdnDescription>CANNABINOIDS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD18</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:04:05.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978123010074</udiDi>
    <basicUdiDi>B-06978123010074</basicUdiDi>
    <tradeName>Okaybio</tradeName>
    <deviceName>Ultra Sensitive THC test kit (Colloidal Gold)</deviceName>
    <manufacturerName>Nanjing Okay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045561</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160505</emdnCode>
    <emdnDescription>CANNABINOIDS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>For Urine 20T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:38:12.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978123010067</udiDi>
    <basicUdiDi>B-06978123010067</basicUdiDi>
    <tradeName>Okaybio</tradeName>
    <deviceName>Ultra Sensitive THC test kit (Colloidal Gold)</deviceName>
    <manufacturerName>Nanjing Okay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045561</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160505</emdnCode>
    <emdnDescription>CANNABINOIDS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>For Urine 10T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:38:12.142Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978123010050</udiDi>
    <basicUdiDi>B-06978123010050</basicUdiDi>
    <tradeName>Okaybio</tradeName>
    <deviceName>Ultra Sensitive THC test kit (Colloidal Gold)</deviceName>
    <manufacturerName>Nanjing Okay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045561</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160505</emdnCode>
    <emdnDescription>CANNABINOIDS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>For Urine 5T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:38:10.538Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978123010043</udiDi>
    <basicUdiDi>B-06978123010043</basicUdiDi>
    <tradeName>Okaybio</tradeName>
    <deviceName>Ultra Sensitive THC test kit (Colloidal Gold)</deviceName>
    <manufacturerName>Nanjing Okay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045561</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160505</emdnCode>
    <emdnDescription>CANNABINOIDS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>For Urine 1T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:38:08.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978123010036</udiDi>
    <basicUdiDi>B-06978123010036</basicUdiDi>
    <tradeName>Okaybio</tradeName>
    <deviceName>Ultra Sensitive THC test kit (Colloidal Gold)</deviceName>
    <manufacturerName>Nanjing Okay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045561</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160505</emdnCode>
    <emdnDescription>CANNABINOIDS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>For Oral Fluid/Saliva 20T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:38:06.826Z</lastUpdated>
  </row>
</eudamedExport>