<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-GBMDP-102aHGXD</udiDi>
    <basicUdiDi>B-GBMDP-102aHGXD</basicUdiDi>
    <tradeName>One Step 3,4-Methylenedioxypyrovalerone Test Cassette (Urine)</tradeName>
    <deviceName>One Step 3,4-Methylenedioxypyrovalerone 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>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBMDP-102a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:18:37.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBMDP-101aHGX6</udiDi>
    <basicUdiDi>B-GBMDP-101aHGX6</basicUdiDi>
    <tradeName>One Step 3,4-Methylenedioxypyrovalerone Test Strip (Urine)</tradeName>
    <deviceName>One Step 3,4-Methylenedioxypyrovalerone 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>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBMDP-101a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:18:33.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBMAM-S102aHGCC</udiDi>
    <basicUdiDi>B-GBMAM-S102aHGCC</basicUdiDi>
    <tradeName>One Step 6-MAM Test Cassette (Urine)</tradeName>
    <deviceName>One Step 6-MAM 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>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBMAM-S102a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:18:31.192Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBMAM-S101aHGC5</udiDi>
    <basicUdiDi>B-GBMAM-S101aHGC5</basicUdiDi>
    <tradeName>One Step 6-MAM Test Strip (Urine)</tradeName>
    <deviceName>One Step 6-MAM 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>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBMAM-S101a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:18:25.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBLSD-102aHG28</udiDi>
    <basicUdiDi>B-GBLSD-102aHG28</basicUdiDi>
    <tradeName>One Step Lysergic Acid Diethylamide Test Cassette  (Urine)</tradeName>
    <deviceName>One Step Lysergic Acid Diethylamide 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>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBLSD-102a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:18:24.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBLSD-101aHGZW</udiDi>
    <basicUdiDi>B-GBLSD-101aHGZW</basicUdiDi>
    <tradeName>One Step Lysergic Acid Diethylamide Test Strip (Urine)</tradeName>
    <deviceName>One Step Lysergic Acid Diethylamide Test Strip</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>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBLSD-101a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:18:19.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBKRA-101aHGWH</udiDi>
    <basicUdiDi>B-GBKRA-101aHGWH</basicUdiDi>
    <tradeName>One Step Kratom Test Strip (Urine)</tradeName>
    <deviceName>One Step Kratom 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>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBKRA-101a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:18:13.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBKRA-102aHGWQ</udiDi>
    <basicUdiDi>B-GBKRA-102aHGWQ</basicUdiDi>
    <tradeName>One Step Kratom Test Cassette (Urine)</tradeName>
    <deviceName>One Step Kratom 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>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBKRA-102a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:18:12.916Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBKET-102aHGYN</udiDi>
    <basicUdiDi>B-GBKET-102aHGYN</basicUdiDi>
    <tradeName>One Step Ketamine Test Cassette (Urine)</tradeName>
    <deviceName>One Step Ketamine 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>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBKET-102a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:17:54.975Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBKET-101aHGYF</udiDi>
    <basicUdiDi>B-GBKET-101aHGYF</basicUdiDi>
    <tradeName>One Step Ketamine Test Strip (Urine)</tradeName>
    <deviceName>One Step Ketamine 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>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBKET-101a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:17:52.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBETG-102aHGWA</udiDi>
    <basicUdiDi>B-GBETG-102aHGWA</basicUdiDi>
    <tradeName>One Step Ethyl Glucuronide Test Cassette (Urine)</tradeName>
    <deviceName>One Step Ethyl Glucuronide 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>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBETG-102a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:17:26.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBETG-101aHGW3</udiDi>
    <basicUdiDi>B-GBETG-101aHGW3</basicUdiDi>
    <tradeName>One Step Ethyl Glucuronide Test Strip (Urine)</tradeName>
    <deviceName>One Step Ethyl Glucuronide 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>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBETG-101a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:17:22.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBCOT-102aHGYL</udiDi>
    <basicUdiDi>B-GBCOT-102aHGYL</basicUdiDi>
    <tradeName>One Step Cotinine Test Cassette (Urine)</tradeName>
    <deviceName>One Step Cotinine 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>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBCOT-102a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:15:41.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBCOT-101aHGYD</udiDi>
    <basicUdiDi>B-GBCOT-101aHGYD</basicUdiDi>
    <tradeName>One Step Cotinine Test Strip (Urine)</tradeName>
    <deviceName>One Step Cotinine 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>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBCOT-101a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:15:41.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBBUP-102aHGZM</udiDi>
    <basicUdiDi>B-GBBUP-102aHGZM</basicUdiDi>
    <tradeName>One Step Buprenorphine Test Cassette (Urine)</tradeName>
    <deviceName>One Step Buprenorphine 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>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBBUP-102a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:15:35.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBBUP-101aHGZE</udiDi>
    <basicUdiDi>B-GBBUP-101aHGZE</basicUdiDi>
    <tradeName>One Step Buprenorphine Test Strip (Urine)</tradeName>
    <deviceName>One Step Buprenorphine 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>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBBUP-101a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:15:29.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBALC-105aHGK7</udiDi>
    <basicUdiDi>B-GBALC-105aHGK7</basicUdiDi>
    <tradeName>Urine Alcohol Test Dip Card</tradeName>
    <deviceName>Urine Alcohol Test Dip Card</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>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBALC-105a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:15:20.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBALC-101aHGJB</udiDi>
    <basicUdiDi>B-GBALC-101aHGJB</basicUdiDi>
    <tradeName>Urine Alcohol Test Strip</tradeName>
    <deviceName>Urine Alcohol Test Strip</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>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBALC-101a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:15:13.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIMF16823xxyyTS2J</udiDi>
    <basicUdiDi>B-FIMF16823xxyyTS2J</basicUdiDi>
    <tradeName>D-FIMF16823xxyyTS2J</tradeName>
    <deviceName>Salofa Single test panel</deviceName>
    <manufacturerName>Salofa Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000016823</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>xxyyT-S</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:33:09.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIMF16823abcxxyyST8J</udiDi>
    <basicUdiDi>B-FIMF16823abcxxyyST8J</basicUdiDi>
    <tradeName>D-FIMF16823abcxxyyST8J</tradeName>
    <deviceName>Salofa Single test</deviceName>
    <manufacturerName>Salofa Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000016823</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>abc-xxyy-ST</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:33:04.086Z</lastUpdated>
  </row>
</eudamedExport>