<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06950996004039</udiDi>
    <basicUdiDi>69509960healgen8008M</basicUdiDi>
    <tradeName>Healgen-800 Urine Analyzer</tradeName>
    <deviceName>Healgen-800 Urine Analyzer</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010701</emdnCode>
    <emdnDescription>URINALYSIS (UR) - LABORATORY ANALYSERS- INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Healgen 800</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:32:15.785Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996004022</udiDi>
    <basicUdiDi>69509960healgen50188</basicUdiDi>
    <tradeName>Urine Analyzer</tradeName>
    <deviceName>Urine Analyzer</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010701</emdnCode>
    <emdnDescription>URINALYSIS (UR) - LABORATORY ANALYSERS- INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Healgen 501</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:32:14.565Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996004015</udiDi>
    <basicUdiDi>69509960healgen50086</basicUdiDi>
    <tradeName>Urine Analyzer</tradeName>
    <deviceName>Urine Analyzer</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010701</emdnCode>
    <emdnDescription>URINALYSIS (UR) - LABORATORY ANALYSERS- INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Healgen 500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:32:08.848Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996003971</udiDi>
    <basicUdiDi>69509960OG-G260MV</basicUdiDi>
    <tradeName>Multiplex Fluorescent Analyzer</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OG-G260</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:32:07.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002844</udiDi>
    <basicUdiDi>69509960GCFCRA-T525aDR65</basicUdiDi>
    <tradeName>COVID-19/Flu A&amp;B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)</tradeName>
    <deviceName>COVID-19/Flu A&amp;B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)</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 Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCFCRA-T525a-DR</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:32:06.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002752</udiDi>
    <basicUdiDi>69509960OG-G300MG</basicUdiDi>
    <tradeName>Hand-Held Immunofluorescence Analyzer</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OG-G300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:32:04.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002745</udiDi>
    <basicUdiDi>69509960OG-G200MB</basicUdiDi>
    <tradeName>Immunofluorescence Analyzer</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OG-G200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:31:58.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002738</udiDi>
    <basicUdiDi>69509960OG-H100MD</basicUdiDi>
    <tradeName>Mini Immunofluorescence Analyzer</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OG-H100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:31:57.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002714</udiDi>
    <basicUdiDi>B-06950996002714</basicUdiDi>
    <tradeName>Digital Pregnancy Test</tradeName>
    <deviceName>Digital Pregnancy Test</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 Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAHCG-D103a-2T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:31:56.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002707</udiDi>
    <basicUdiDi>B-06950996002707</basicUdiDi>
    <tradeName>Digital Pregnancy Test</tradeName>
    <deviceName>Digital Pregnancy Test</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 Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAHCG-D103a-1T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:31:55.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002691</udiDi>
    <basicUdiDi>B-06950996002691</basicUdiDi>
    <tradeName>HCG Pregnancy Rapid Test</tradeName>
    <deviceName>HCG Pregnancy Rapid Test</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 Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAHCG-103a-5T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:31:49.834Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002684</udiDi>
    <basicUdiDi>69509960OG-H180N5</basicUdiDi>
    <tradeName>Immunofluorescence Analyzer</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OG-H180</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:31:48.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002646</udiDi>
    <basicUdiDi>69509960GCFLUAB502aDRHGQ</basicUdiDi>
    <tradeName>Rapid Influenza A &amp; B Antigen Test</tradeName>
    <deviceName>Rapid Influenza A &amp; B Antigen Test</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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCFLU(A/B)-502a-DRH20</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:31:46.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002622</udiDi>
    <basicUdiDi>69509960GCFLUAB502aDRHGQ</basicUdiDi>
    <tradeName>Rapid Influenza A &amp; B Antigen Test</tradeName>
    <deviceName>Rapid Influenza A &amp; B Antigen Test</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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCFLU(A/B)-502a-DRH5</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:31:45.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002608</udiDi>
    <basicUdiDi>69509960GCFLUAB502aDRHGQ</basicUdiDi>
    <tradeName>Rapid Influenza A &amp; B Antigen Test</tradeName>
    <deviceName>Rapid Influenza A &amp; B Antigen Test</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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCFLU(A/B)-502a-DRH1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:31:39.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002462</udiDi>
    <basicUdiDi>B-06950996002462</basicUdiDi>
    <tradeName>Rotavirus Rapid Test Cassette (Feces)</tradeName>
    <deviceName>Rotavirus Rapid Test Cassette (Feces)</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>W0105040606</emdnCode>
    <emdnDescription>ROTAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCROA-602a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:31:38.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002448</udiDi>
    <basicUdiDi>B-06950996002448</basicUdiDi>
    <tradeName>Fecal Occult Blood Rapid Test Cassette (Feces)</tradeName>
    <deviceName>Fecal Occult Blood Rapid Test Cassette (Feces)</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>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GEFOB-602b</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:31:37.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002431</udiDi>
    <basicUdiDi>B-06950996002431</basicUdiDi>
    <tradeName>RSV Antigen Rapid Test Cassette (Swab)</tradeName>
    <deviceName>RSV Antigen Rapid Test Cassette (Swab)</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>W0105099002</emdnCode>
    <emdnDescription>RSV - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCRSV-502a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:31:36.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002394</udiDi>
    <basicUdiDi>B-06950996002394</basicUdiDi>
    <tradeName>Influenza A &amp; B Ag Rapid Test Cassette (Swab)</tradeName>
    <deviceName>Influenza A &amp; B Ag Rapid Test Cassette (Swab)</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>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCFLU(A/B)-502Ca</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:31:30.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002387</udiDi>
    <basicUdiDi>B-06950996002387</basicUdiDi>
    <tradeName>Influenza A &amp; B Ag Rapid Test Cassette (Swab)</tradeName>
    <deviceName>Influenza A &amp; B Ag Rapid Test Cassette (Swab)</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>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCFLU(A/B)-502a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:31:29.332Z</lastUpdated>
  </row>
</eudamedExport>