<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>
  <row>
    <udiDi>D-GBALC-101aPZ</udiDi>
    <basicUdiDi>B-GBALC-101aPZ</basicUdiDi>
    <tradeName>Urine Alcohol Test Strip</tradeName>
    <deviceName>Urine Alcohol Test Strip</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>GBALC-101a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:15:19.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001963</udiDi>
    <basicUdiDi>0405686901158VE</basicUdiDi>
    <tradeName>Emit II Plus Phencyclidine Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090114</emdnCode>
    <emdnDescription>PHENCYCLIDINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445443</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:51.563Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001925</udiDi>
    <basicUdiDi>0405686901169VK</basicUdiDi>
    <tradeName>Emit II Plus Propoxyphene Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090115</emdnCode>
    <emdnDescription>PROPOXYPHENE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445435</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:43.999Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001826</udiDi>
    <basicUdiDi>0405686901152V2</basicUdiDi>
    <tradeName>Emit II Plus Opiate Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445417</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:42.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768014383</udiDi>
    <basicUdiDi>0405686901169VK</basicUdiDi>
    <tradeName>Emit II Plus Propoxyphene Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090115</emdnCode>
    <emdnDescription>PROPOXYPHENE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445434</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:38.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768014338</udiDi>
    <basicUdiDi>0405686901152V2</basicUdiDi>
    <tradeName>Emit II Plus Opiate Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445414</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:38.075Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768014406</udiDi>
    <basicUdiDi>0405686901158VE</basicUdiDi>
    <tradeName>Emit II Plus Phencyclidine Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090114</emdnCode>
    <emdnDescription>PHENCYCLIDINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445442</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:28.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FRMF-000000509-RicineUC</udiDi>
    <basicUdiDi>B-FRMF-000000509-RicineUC</basicUdiDi>
    <tradeName>ELISA Ricine eZYDIAG®</tradeName>
    <deviceName>ELISA Ricine eZYDIAG®</deviceName>
    <manufacturerName>Laboratoire Aguettant</manufacturerName>
    <manufacturerSrn>FR-MF-000000509</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090299</emdnCode>
    <emdnDescription>TOXICOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELISA Ricine eZYDIAG®</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:43:52.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FBFEN-102aSW</udiDi>
    <basicUdiDi>B-FBFEN-102aSW</basicUdiDi>
    <tradeName>Fentanyl Rapid Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName>Fentanyl Rapid Test Kit (Time-Resolved FIA)</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>W0102090122</emdnCode>
    <emdnDescription>FENTANYL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FBFEN-102a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:17:34.885Z</lastUpdated>
  </row>
</eudamedExport>