<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-FAPRL-402a6Y</udiDi>
    <basicUdiDi>B-FAPRL-402a6Y</basicUdiDi>
    <tradeName>PRL Quantitative Test Kit (Time-Resolved FIA)</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>FAPRL-402a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:02:20.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FAPRO-402a87</udiDi>
    <basicUdiDi>B-FAPRO-402a87</basicUdiDi>
    <tradeName>PROG Quantitative Test Kit (Time-Resolved FIA)</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>FAPRO-402a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:02:20.524Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FAPRO-PN20FX</udiDi>
    <basicUdiDi>B-FAPRO-PN20FX</basicUdiDi>
    <tradeName>PROG Control</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>FAPRO-PN20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:02:20.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FBFEN-102aSW</udiDi>
    <basicUdiDi>B-FBFEN-102aSW</basicUdiDi>
    <tradeName>Fentanyl Rapid Test Kit (Time-Resolved FIA)</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>FBFEN-102a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:02:20.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FBXXX-1102/FBDOA-11X529</udiDi>
    <basicUdiDi>B-FBXXX-1102/FBDOA-11X529</basicUdiDi>
    <tradeName>Hair Drug Rapid Test Kit (Time-Resolved FIA)</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>FBXXX-1102/FBDOA-11X5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:02:20.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FBxxx-702aWL</udiDi>
    <basicUdiDi>B-FBxxx-702aWL</basicUdiDi>
    <tradeName>Oral Fluid Drug Test Kit (FIA)</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>FBxxx-702a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:02:20.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FCADE-502aMC</udiDi>
    <basicUdiDi>B-FCADE-502aMC</basicUdiDi>
    <tradeName>Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab)</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>FCADE-502a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:02:19.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FCADE-502CaEN</udiDi>
    <basicUdiDi>B-FCADE-502CaEN</basicUdiDi>
    <tradeName>Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab)</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>FCADE-502Ca</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:02:19.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FCADE-PN22U</udiDi>
    <basicUdiDi>B-FCADE-PN22U</basicUdiDi>
    <tradeName>Adenovirus Antigen FIA Control Kit</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>FCADE-PN2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:02:19.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FCCOV-502a3D</udiDi>
    <basicUdiDi>B-FCCOV-502a3D</basicUdiDi>
    <tradeName>SARS-CoV-2 Ag Fluorescence Rapid Test Cassette (Swab)</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>FCCOV-502a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:02:19.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FCFC-T502aTH</udiDi>
    <basicUdiDi>B-FCFC-T502aTH</basicUdiDi>
    <tradeName>SARS-CoV-2 + Flu A&amp;B Ag Test Kit (Time-Resolved FIA)</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>FCFC-T502a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:02:19.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FCFLU(A)-502aVJ</udiDi>
    <basicUdiDi>B-FCFLU(A)-502aVJ</basicUdiDi>
    <tradeName>Flu A Ag Fluorescent Rapid Test Cassette (Time-Resolved FIA)</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>FCFLU(A)-502a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:02:19.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FCFLU(A/B)-502FaMA</udiDi>
    <basicUdiDi>B-FCFLU(A/B)-502FaMA</basicUdiDi>
    <tradeName>Influenza A&amp;B Ag Test Kit (Time-Resolved FIA)</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>FCFLU(A/B)-502Fa</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:02:19.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FCFLU(AH5)-502aGT</udiDi>
    <basicUdiDi>B-FCFLU(AH5)-502aGT</basicUdiDi>
    <tradeName>Flu A(H5) Ag Fluorescent Rapid Test Cassette (Time-Resolved FIA)</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>FCFLU(AH5)-502a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:02:19.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FCGON-502a2H</udiDi>
    <basicUdiDi>B-FCGON-502a2H</basicUdiDi>
    <tradeName>Healgen® Gonorrhoea Fluorescent Rapid Test</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>FCGON-502a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:02:18.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FCHPIV-502a9T</udiDi>
    <basicUdiDi>B-FCHPIV-502a9T</basicUdiDi>
    <tradeName>HPIV Antigen Rapid Test Kit (Time-Resolved FIA)</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>FCHPIV-502a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:02:18.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FCRA-T502aZK</udiDi>
    <basicUdiDi>B-FCRA-T502aZK</basicUdiDi>
    <tradeName>RSV/Adenovirus Antigen Combo Fluorescence Rapid Test Cassette (Swab)</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>FCRA-T502a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:02:18.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FCRSV-502aEE</udiDi>
    <basicUdiDi>B-FCRSV-502aEE</basicUdiDi>
    <tradeName>D-FCRSV-502aEE</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>FCRSV-502a</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:02:18.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FCRSV-502CaCW</udiDi>
    <basicUdiDi>B-FCRSV-502CaCW</basicUdiDi>
    <tradeName>RSV Antigen Fluorescence Rapid Test Cassette (Swab)</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>FCRSV-502Ca</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:02:18.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FCRSV-PN2PT</udiDi>
    <basicUdiDi>B-FCRSV-PN2PT</basicUdiDi>
    <tradeName>RSV Antigen FIA Control Kit</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>FCRSV-PN2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:02:18.505Z</lastUpdated>
  </row>
</eudamedExport>