<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-GCCOV(Del)-T502aUL</udiDi>
    <basicUdiDi>B-GCCOV(Del)-T502aUL</basicUdiDi>
    <tradeName>SARS-CoV-2 Delta-series Mutant Strain Ag Rapid Test Cassette (Swab)</tradeName>
    <deviceName>SARS-CoV-2 Delta-series Mutant Strain 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>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV(Del)-T502a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:50.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV(Del)-T502aHGQG</udiDi>
    <basicUdiDi>B-GCCOV(Del)-T502aHGQG</basicUdiDi>
    <tradeName>SARS-CoV-2 Delta-series Mutant Strain Ag Rapid Test Cassette (Swab)</tradeName>
    <deviceName>SARS-CoV-2 Delta-series Mutant Strain Ag Rapid Test Cassette (Swab)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV(Del)-T502a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:49.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV(B117)-525aKE</udiDi>
    <basicUdiDi>B-GCCOV(B117)-525aKE</basicUdiDi>
    <tradeName>COVID-19 Ag &amp; B.1.1.7 Mutant Strain Combo Test Cassette (Swab)</tradeName>
    <deviceName>COVID-19 Ag &amp; B.1.1.7 Mutant Strain Combo 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>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV(B117)-525a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:49.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV(B117)-525aHGE5</udiDi>
    <basicUdiDi>B-GCCOV(B117)-525aHGE5</basicUdiDi>
    <tradeName>COVID-19 Ag &amp; B.1.1.7 Mutant Strain Combo Test Cassette (Swab)</tradeName>
    <deviceName>COVID-19 Ag &amp; B.1.1.7 Mutant Strain Combo Test Cassette (Swab)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV(B117)-525a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:45.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV(Ag)-PNF6</udiDi>
    <basicUdiDi>B-GCCOV(Ag)-PNF6</basicUdiDi>
    <tradeName>COVID-19 Antigen Control Kit</tradeName>
    <deviceName>COVID-19 Antigen Control Kit</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>W0105094001</emdnCode>
    <emdnDescription>CONTROLS INFECTIOUS IMMUNOLOGY - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV(Ag)-PN10，GCCOV(Ag)-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:44.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV(Ag)-PN20HG4Y</udiDi>
    <basicUdiDi>B-GCCOV(Ag)-PN20HG4Y</basicUdiDi>
    <tradeName>COVID-19 Antigen Control Kit</tradeName>
    <deviceName>COVID-19 Antigen Control Kit</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105094001</emdnCode>
    <emdnDescription>CONTROLS INFECTIOUS IMMUNOLOGY - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV(Ag)-PN20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:43.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCOV(Ag)-PN10HG4R</udiDi>
    <basicUdiDi>B-GCCOV(Ag)-PN10HG4R</basicUdiDi>
    <tradeName>COVID-19 Antigen Control Kit</tradeName>
    <deviceName>COVID-19 Antigen Control Kit</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105094001</emdnCode>
    <emdnDescription>CONTROLS INFECTIOUS IMMUNOLOGY - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCOV(Ag)-PN10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:42.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCD-602aHGCS</udiDi>
    <basicUdiDi>B-GCCD-602aHGCS</basicUdiDi>
    <tradeName>Clostridium difficile GDH &amp; Toxin A/B Rapid Test Cassette (Feces)</tradeName>
    <deviceName>Clostridium difficile GDH &amp; Toxin A/B Rapid Test Cassette (Feces)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090106</emdnCode>
    <emdnDescription>CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCD-602a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:13.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCD(ToxinA/B)-602aHG5N</udiDi>
    <basicUdiDi>B-GCCD(ToxinA/B)-602aHG5N</basicUdiDi>
    <tradeName>Clostridium difficile Toxin A&amp;B Rapid Test Cassette (Feces)</tradeName>
    <deviceName>Clostridium difficile Toxin A&amp;B Rapid Test Cassette (Feces)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090106</emdnCode>
    <emdnDescription>CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCD(Toxin A/B)-602a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:11.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCD(GDH)-602aHG2C</udiDi>
    <basicUdiDi>B-GCCD(GDH)-602aHG2C</basicUdiDi>
    <tradeName>Clostridium difficile Antigen GDH Rapid Test Cassette (Feces)</tradeName>
    <deviceName>Clostridium difficile Antigen GDH Rapid Test Cassette (Feces)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090106</emdnCode>
    <emdnDescription>CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCD(GDH)-602a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:10.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2M706221FF</udiDi>
    <basicUdiDi>B-G2M706221FF</basicUdiDi>
    <tradeName>Malaria-Q Real-Time PCR Kit</tradeName>
    <deviceName>Malaria-Q Real-Time PCR Kit</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M706221, G2M706221R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:43:50.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2M706021F5</udiDi>
    <basicUdiDi>B-G2M706021F5</basicUdiDi>
    <tradeName>Influenza A/B-Q Real Time PCR Kit</tradeName>
    <deviceName>Influenza A/B-Q Real Time PCR Kit</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>G2M706021, G2M706021R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:43:49.106Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2M705821G6</udiDi>
    <basicUdiDi>B-G2M705821G6</basicUdiDi>
    <tradeName>VZV-Q Real-Time PCR Kit for Varicella-zoster virus</tradeName>
    <deviceName>VZV-Q Real-Time PCR Kit for Varicella-zoster virus</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099006</emdnCode>
    <emdnDescription>VZV - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M705821,G2M705821R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:43:44.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440205999</udiDi>
    <basicUdiDi>84354402IDXGASTROB_RT8H</basicUdiDi>
    <tradeName>CerTest Rotavirus+Adenovirus+Astrovirus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>RT872001VC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:59:12.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440207641</udiDi>
    <basicUdiDi>84354402IDXGASTROB_RT8H</basicUdiDi>
    <tradeName>CerTest Rotavirus+Adenovirus+Astrovirus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>RT872001VCC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:59:12.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440206057</udiDi>
    <basicUdiDi>84354402IDXGASTROB_XR8X</basicUdiDi>
    <tradeName>CerTest Rotavirus+Adenovirus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>XR882001VC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:59:11.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440207740</udiDi>
    <basicUdiDi>84354402IDXGASTROB_XR8X</basicUdiDi>
    <tradeName>CerTest Rotavirus+Adenovirus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>XR882001VCC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:58:56.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440201519</udiDi>
    <basicUdiDi>84354402IDXGASTROB_GD6G</basicUdiDi>
    <tradeName>CerTest Clostridium difficile antigen GDH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090106</emdnCode>
    <emdnDescription>CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GD820001VC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:58:42.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440207498</udiDi>
    <basicUdiDi>84354402IDXGASTROB_GD6G</basicUdiDi>
    <tradeName>CerTest Clostridium difficile antigen GDH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090106</emdnCode>
    <emdnDescription>CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GD820001VCC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:58:13.986Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440206200</udiDi>
    <basicUdiDi>84354402IDXGASTROB_CD64</basicUdiDi>
    <tradeName>CerTest Clostridium difficile Toxin A+B</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090106</emdnCode>
    <emdnDescription>CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD882001VC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:57:12.002Z</lastUpdated>
  </row>
</eudamedExport>