<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-GBBUP-102a2U</udiDi>
    <basicUdiDi>B-GBBUP-102a2U</basicUdiDi>
    <tradeName>One Step Buprenorphine Test Cassette (Urine)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBBUP-102a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:58.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBCOT-102aZS</udiDi>
    <basicUdiDi>B-GBCOT-102aZS</basicUdiDi>
    <tradeName>One Step Cotinine Test Cassette (Urine)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBCOT-102a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:58.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBDOA-11X5TW</udiDi>
    <basicUdiDi>B-GBDOA-11X5TW</basicUdiDi>
    <tradeName>Drugs of Abuse Rapid Test Cassette(Hair)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBDOA-11X5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:58.271Z</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></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBDOA-1X4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:58.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBDOA-1X646</udiDi>
    <basicUdiDi>B-GBDOA-1X646</basicUdiDi>
    <tradeName>One Step Multi-Drug Screen Test Cup  (Urine)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBDOA-1X6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:58.099Z</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></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBDOAA-1X6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:58.025Z</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></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBDOAVC-1X6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:57.945Z</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></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBDSA-XXXXA/B/G/H/I</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:57.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBDSA-XXXXCXW4</udiDi>
    <basicUdiDi>B-GBDSA-XXXXCXW4</basicUdiDi>
    <tradeName>Oral Fluid Drug Test Cylinder</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBDSA-XXXXCX</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:57.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBDSA-XXXXEXWA</udiDi>
    <basicUdiDi>B-GBDSA-XXXXEXWA</basicUdiDi>
    <tradeName>Oral Fluid Drug Test</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBDSA-XXXXEX</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:57.630Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBDSA-XXXXFSIGQ</udiDi>
    <basicUdiDi>B-GBDSA-XXXXFSIGQ</basicUdiDi>
    <tradeName>Oral Fluid Drug Test Cube</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBDSA-XXXXFSI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:57.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBDSA-XXXXFXWD</udiDi>
    <basicUdiDi>B-GBDSA-XXXXFXWD</basicUdiDi>
    <tradeName>Oral Fluid Drug Test Cube</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBDSA-XXXXFX</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:57.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBDSA-XXXXJXWR</udiDi>
    <basicUdiDi>B-GBDSA-XXXXJXWR</basicUdiDi>
    <tradeName>Oral Fluid Drug Test Cylinder</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBDSA-XXXXJX</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:57.027Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBDSA-XXXXKXWU</udiDi>
    <basicUdiDi>B-GBDSA-XXXXKXWU</basicUdiDi>
    <tradeName>Oral Fluid Drug Test Cylinder</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBDSA-XXXXKX</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:56.937Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBDSA-XXXXLXWX</udiDi>
    <basicUdiDi>B-GBDSA-XXXXLXWX</basicUdiDi>
    <tradeName>Oral Fluid Drug Test Mini Cube</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBDSA-XXXXLX</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:56.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBDSA-XXXXMXX2</udiDi>
    <basicUdiDi>B-GBDSA-XXXXMXX2</basicUdiDi>
    <tradeName>Oral Fluid Drug Test Device</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBDSA-XXXXMX</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:56.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBEDD-101aNJ</udiDi>
    <basicUdiDi>B-GBEDD-101aNJ</basicUdiDi>
    <tradeName>One Step EDDP Test Strip (Urine)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBEDD-101a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:56.544Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBEDD-102aNM</udiDi>
    <basicUdiDi>B-GBEDD-102aNM</basicUdiDi>
    <tradeName>One Step EDDP Test Cassette (Urine)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBEDD-102a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:56.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBETG-101bYB</udiDi>
    <basicUdiDi>B-GBETG-101bYB</basicUdiDi>
    <tradeName>One Step Ethyl Glucuronide Test Strip (Urine)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBETG-101b</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:56.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBETG-102bYE</udiDi>
    <basicUdiDi>B-GBETG-102bYE</basicUdiDi>
    <tradeName>One Step Ethyl Glucuronide Test Cassette (Urine)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBETG-102b</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:56.324Z</lastUpdated>
  </row>
</eudamedExport>