<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-GBKET-101aZ5</udiDi>
    <basicUdiDi>B-GBKET-101aZ5</basicUdiDi>
    <tradeName>One Step Ketamine Test Strip (Urine)</tradeName>
    <deviceName>One Step Ketamine Test Strip (Urine)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBKET-101a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:17:54.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBK2-102aMF</udiDi>
    <basicUdiDi>B-GBK2-102aMF</basicUdiDi>
    <tradeName>One Step K2 Test Cassette (Urine)</tradeName>
    <deviceName>One Step K2 Test Cassette (Urine)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090105</emdnCode>
    <emdnDescription>CANNABINOIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBK2-102a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:17:48.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBK2-101aMC</udiDi>
    <basicUdiDi>B-GBK2-101aMC</basicUdiDi>
    <tradeName>One Step K2 Test Strip (Urine)</tradeName>
    <deviceName>One Step K2 Test Strip (Urine)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090105</emdnCode>
    <emdnDescription>CANNABINOIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBK2-101a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:17:43.691Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBHCD-102aPV</udiDi>
    <basicUdiDi>B-GBHCD-102aPV</basicUdiDi>
    <tradeName>One Step Hydrocodone Test Cassette (Urine)</tradeName>
    <deviceName>One Step Hydrocodone Test Cassette (Urine)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBHCD-102a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:17:41.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBHCD-101aPS</udiDi>
    <basicUdiDi>B-GBHCD-101aPS</basicUdiDi>
    <tradeName>One Step Hydrocodone Test Strip (Urine)</tradeName>
    <deviceName>One Step Hydrocodone Test Strip (Urine)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBHCD-101a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:17:37.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBFEN-102bTV</udiDi>
    <basicUdiDi>B-GBFEN-102bTV</basicUdiDi>
    <tradeName>One Step Fentanyl Test Cassette (Urine)</tradeName>
    <deviceName>One Step Fentanyl Test Cassette (Urine)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090122</emdnCode>
    <emdnDescription>FENTANYL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBFEN-102b</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:17:34.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBFEN-101bTS</udiDi>
    <basicUdiDi>B-GBFEN-101bTS</basicUdiDi>
    <tradeName>One Step Fentanyl Test Strip (Urine)</tradeName>
    <deviceName>One Step Fentanyl Test Strip (Urine)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090122</emdnCode>
    <emdnDescription>FENTANYL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBFEN-101b</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:17:30.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBETG-102bYE</udiDi>
    <basicUdiDi>B-GBETG-102bYE</basicUdiDi>
    <tradeName>One Step Ethyl Glucuronide Test Cassette (Urine)</tradeName>
    <deviceName>One Step Ethyl Glucuronide Test Cassette (Urine)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090220</emdnCode>
    <emdnDescription>ETHYL GLUCURONIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBETG-102b</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:17:28.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBETG-101bYB</udiDi>
    <basicUdiDi>B-GBETG-101bYB</basicUdiDi>
    <tradeName>One Step Ethyl Glucuronide Test Strip (Urine)</tradeName>
    <deviceName>One Step Ethyl Glucuronide Test Strip (Urine)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090220</emdnCode>
    <emdnDescription>ETHYL GLUCURONIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBETG-101b</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:17:23.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBEDD-102aNM</udiDi>
    <basicUdiDi>B-GBEDD-102aNM</basicUdiDi>
    <tradeName>One Step EDDP Test Cassette (Urine)</tradeName>
    <deviceName>One Step EDDP Test Cassette (Urine)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090120</emdnCode>
    <emdnDescription>EDDP SPECIFIC (METHADONE METABOLITES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBEDD-102a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:17:21.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBEDD-101aNJ</udiDi>
    <basicUdiDi>B-GBEDD-101aNJ</basicUdiDi>
    <tradeName>One Step EDDP Test Strip (Urine)</tradeName>
    <deviceName>One Step EDDP Test Strip (Urine)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090120</emdnCode>
    <emdnDescription>EDDP SPECIFIC (METHADONE METABOLITES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBEDD-101a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:17:14.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBDSA-XXXXMXX2</udiDi>
    <basicUdiDi>B-GBDSA-XXXXMXX2</basicUdiDi>
    <tradeName>Oral Fluid Drug Test Device</tradeName>
    <deviceName>Oral Fluid Drug Test Device</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBDSA-XXXXMX</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:16:53.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBDSA-XXXXLXWX</udiDi>
    <basicUdiDi>B-GBDSA-XXXXLXWX</basicUdiDi>
    <tradeName>Oral Fluid Drug Test Mini Cube</tradeName>
    <deviceName>Oral Fluid Drug Test Mini Cube</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBDSA-XXXXLX</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:16:48.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBDSA-XXXXKXWU</udiDi>
    <basicUdiDi>B-GBDSA-XXXXKXWU</basicUdiDi>
    <tradeName>Oral Fluid Drug Test Cylinder</tradeName>
    <deviceName>Oral Fluid Drug Test Cylinder</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBDSA-XXXXKX</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:16:47.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBDSA-XXXXJXWR</udiDi>
    <basicUdiDi>B-GBDSA-XXXXJXWR</basicUdiDi>
    <tradeName>Oral Fluid Drug Test Cylinder</tradeName>
    <deviceName>Oral Fluid Drug Test Cylinder</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBDSA-XXXXJX</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:16:41.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBDSA-XXXXFXWD</udiDi>
    <basicUdiDi>B-GBDSA-XXXXFXWD</basicUdiDi>
    <tradeName>Oral Fluid Drug Test Cube</tradeName>
    <deviceName>Oral Fluid Drug Test Cube</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBDSA-XXXXFX</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:16:33.978Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBDSA-XXXXFSIGQ</udiDi>
    <basicUdiDi>B-GBDSA-XXXXFSIGQ</basicUdiDi>
    <tradeName>Oral Fluid Drug Test Cube</tradeName>
    <deviceName>Oral Fluid Drug Test Cube</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBDSA-XXXXFSI</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:16:27.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBDSA-XXXXEXWA</udiDi>
    <basicUdiDi>B-GBDSA-XXXXEXWA</basicUdiDi>
    <tradeName>Oral Fluid Drug Test</tradeName>
    <deviceName>Oral Fluid Drug Test</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBDSA-XXXXEX</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:16:26.799Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBDSA-XXXXCXW4</udiDi>
    <basicUdiDi>B-GBDSA-XXXXCXW4</basicUdiDi>
    <tradeName>Oral Fluid Drug Test Cylinder</tradeName>
    <deviceName>Oral Fluid Drug Test Cylinder</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBDSA-XXXXCX</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:16:22.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBDSA-XXXXA/B/G/H/IFW</udiDi>
    <basicUdiDi>B-GBDSA-XXXXA/B/G/H/IFW</basicUdiDi>
    <tradeName>Multi-Drug Rapid Screen Test Cassette (Oral Fluid)</tradeName>
    <deviceName>Multi-Drug Rapid Screen Test Cassette (Oral Fluid)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBDSA-XXXXA/B/G/H/I</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:16:18.763Z</lastUpdated>
  </row>
</eudamedExport>