<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>
  <row>
    <udiDi>D-GBDOAVC-1X68X</udiDi>
    <basicUdiDi>B-GBDOAVC-1X68X</basicUdiDi>
    <tradeName>One Step Multi-Drug Screen Test Vacuum Cup (Urine)</tradeName>
    <deviceName>One Step Multi-Drug Screen Test Vacuum Cup (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>GBDOAVC-1X6</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:16:13.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBDOAA-1X6ZM</udiDi>
    <basicUdiDi>B-GBDOAA-1X6ZM</basicUdiDi>
    <tradeName>One Step Multi-Drug Screen Test Key Cup (Urine)</tradeName>
    <deviceName>One Step Multi-Drug Screen Test Key Cup (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>GBDOAA-1X6</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:16:12.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBDOA-1X646</udiDi>
    <basicUdiDi>B-GBDOA-1X646</basicUdiDi>
    <tradeName>One Step Multi-Drug Screen Test Cup  (Urine)</tradeName>
    <deviceName>One Step Multi-Drug Screen Test Cup  (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>GBDOA-1X6</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:15:55.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBDOA-1X442</udiDi>
    <basicUdiDi>B-GBDOA-1X442</basicUdiDi>
    <tradeName>One Step Multi-Drug Screen Test Dip Card (Urine)</tradeName>
    <deviceName>One Step Multi-Drug Screen Test Dip Card (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>GBDOA-1X4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:15:51.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBDOA-11X5TW</udiDi>
    <basicUdiDi>B-GBDOA-11X5TW</basicUdiDi>
    <tradeName>Drugs of Abuse Rapid Test Cassette(Hair)</tradeName>
    <deviceName>Drugs of Abuse Rapid Test Cassette(Hair)</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>GBDOA-11X5</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:15:51.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBCOT-102aZS</udiDi>
    <basicUdiDi>B-GBCOT-102aZS</basicUdiDi>
    <tradeName>One Step Cotinine Test Cassette (Urine)</tradeName>
    <deviceName>One Step Cotinine 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>W0102090108</emdnCode>
    <emdnDescription>COTININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBCOT-102a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:15:42.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBBUP-102a2U</udiDi>
    <basicUdiDi>B-GBBUP-102a2U</basicUdiDi>
    <tradeName>One Step Buprenorphine Test Cassette (Urine)</tradeName>
    <deviceName>One Step Buprenorphine 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>W0102090117</emdnCode>
    <emdnDescription>BUPRENORPHINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBBUP-102a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:15:34.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBBUP-101a2R</udiDi>
    <basicUdiDi>B-GBBUP-101a2R</basicUdiDi>
    <tradeName>One Step Buprenorphine Test Strip (Urine)</tradeName>
    <deviceName>One Step Buprenorphine 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>W0102090117</emdnCode>
    <emdnDescription>BUPRENORPHINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBBUP-101a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:15:29.113Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBALC-105aQD</udiDi>
    <basicUdiDi>B-GBALC-105aQD</basicUdiDi>
    <tradeName>Urine Alcohol Test Dip Card</tradeName>
    <deviceName>Urine Alcohol Test Dip Card</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>GBALC-105a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:15:21.894Z</lastUpdated>
  </row>
</eudamedExport>