<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-GCCD-602aRS</udiDi>
    <basicUdiDi>B-GCCD-602aRS</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>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>W0105011803</emdnCode>
    <emdnDescription>C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCD-602a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:17.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCD(ToxinAB)-602aZC</udiDi>
    <basicUdiDi>B-GCCD(ToxinAB)-602aZC</basicUdiDi>
    <tradeName>Clostridium difficile Toxin A&amp;B Rapid Test Casette (Feces)</tradeName>
    <deviceName>Clostridium difficile Toxin A&amp;B Rapid Test Casette (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>W0105011802</emdnCode>
    <emdnDescription>C.DIFFICILE TOXIN A/B DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCD(Toxin A/B)-602a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:12.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCBRU-402aHG4Q</udiDi>
    <basicUdiDi>B-GCBRU-402aHG4Q</basicUdiDi>
    <tradeName>Brucella Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Brucella Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma)</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>W0105011701</emdnCode>
    <emdnDescription>BRUCELLA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCBRU-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:05.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCD(GDH)-602aH3</udiDi>
    <basicUdiDi>B-GCCD(GDH)-602aH3</basicUdiDi>
    <tradeName>Clostridium difficile Antigen GDH Rapid Test Cassette (Feces)</tradeName>
    <deviceName>Clostridium difficile Antigen GDH 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>W0105011801</emdnCode>
    <emdnDescription>C.DIFFICILE GDH DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCD(GDH)-602a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:23:05.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCBRU-402a4N</udiDi>
    <basicUdiDi>B-GCBRU-402a4N</basicUdiDi>
    <tradeName>Brucella Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Brucella Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma)</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>W0105011701</emdnCode>
    <emdnDescription>BRUCELLA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCBRU-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:22:47.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCBRU(IgG/IgM)-402aHGMN</udiDi>
    <basicUdiDi>B-GCBRU(IgG/IgM)-402aHGMN</basicUdiDi>
    <tradeName>Brucella IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Brucella IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</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>W0105011701</emdnCode>
    <emdnDescription>BRUCELLA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCBRU(IgG/IgM)-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:22:46.690Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCBRU(IgG/IgM)-402a3Y</udiDi>
    <basicUdiDi>B-GCBRU(IgG/IgM)-402a3Y</basicUdiDi>
    <tradeName>Brucella IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Brucella IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</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>W0105011701</emdnCode>
    <emdnDescription>BRUCELLA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCBRU(IgG/IgM)-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:22:45.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2MR172515JP</udiDi>
    <basicUdiDi>B-G2MR172515JP</basicUdiDi>
    <tradeName>RapiSyph Rapid Antibody Test kit for Syphilis</tradeName>
    <deviceName>RapiSyph Rapid Antibody Test kit for Syphilis</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>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2MR172515, G2MR170115</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:46:14.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2MMAP10001LS</udiDi>
    <basicUdiDi>B-G2MMAP10001LS</basicUdiDi>
    <tradeName>Med4Me Tuberculosis Panel</tradeName>
    <deviceName>Med4Me Tuberculosis Panel</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>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2MMAP10001-ill; G2MMAP10001-TF; G2MMAP10001-MG</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:45:51.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2M803121F2</udiDi>
    <basicUdiDi>B-G2M803121F2</basicUdiDi>
    <tradeName>TB-Q Comprehensive Real Time PCR Kit for Tuberculosis</tradeName>
    <deviceName>TB-Q Comprehensive Real Time PCR Kit for Tuberculosis</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>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M803121,G2M803121R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:45:10.078Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2M706421FR</udiDi>
    <basicUdiDi>B-G2M706421FR</basicUdiDi>
    <tradeName>N. Gonorrhoeae-Q Real-Time PCR Kit</tradeName>
    <deviceName>N. Gonorrhoeae-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>W0105010203</emdnCode>
    <emdnDescription>GONOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M706421, G2M706421R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:44:10.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2M707321FT</udiDi>
    <basicUdiDi>B-G2M707321FT</basicUdiDi>
    <tradeName>MTC-Q Real-Time PCR Kit</tradeName>
    <deviceName>MTC-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>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M707321,G2M707321R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:44:08.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2M706321FL</udiDi>
    <basicUdiDi>B-G2M706321FL</basicUdiDi>
    <tradeName>H. Pylori-Q Real-Time PCR Kit</tradeName>
    <deviceName>H. Pylori-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>W0105010403</emdnCode>
    <emdnDescription>H. PYLORI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M706321</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:43:51.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-G2M705521FP</udiDi>
    <basicUdiDi>B-G2M705521FP</basicUdiDi>
    <tradeName>Syphilis-Q Real Time PCR Kit</tradeName>
    <deviceName>Syphilis-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>W0105010305</emdnCode>
    <emdnDescription>SYPHILIS DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M705521, G2M705521R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:43:38.698Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FCGON-502aHG27</udiDi>
    <basicUdiDi>B-FCGON-502aHG27</basicUdiDi>
    <tradeName>Healgen® Gonorrhoea Fluorescent Rapid Test</tradeName>
    <deviceName></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>W0105010201</emdnCode>
    <emdnDescription>GONOCOCCAL ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCGON-502a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:18:37.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FCGON-502a2H</udiDi>
    <basicUdiDi>B-FCGON-502a2H</basicUdiDi>
    <tradeName>Healgen® Gonorrhoea Fluorescent Rapid Test</tradeName>
    <deviceName>Healgen® Gonorrhoea Fluorescent 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010201</emdnCode>
    <emdnDescription>GONOCOCCAL ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCGON-502a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:18:36.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4205323FL</udiDi>
    <basicUdiDi>B-EIM4205323FL</basicUdiDi>
    <tradeName>D-EIM4205323FL</tradeName>
    <deviceName>Treponema Pallidum Antibody (anti-TP) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4205323</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:53:05.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4202323EX</udiDi>
    <basicUdiDi>B-EIM4202323EX</basicUdiDi>
    <tradeName>D-EIM4202323EX</tradeName>
    <deviceName>Treponema Pallidum Antibody (anti-TP) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4202323</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:48:32.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4201323EQ</udiDi>
    <basicUdiDi>B-EIM4201323EQ</basicUdiDi>
    <tradeName>D-EIM4201323EQ</tradeName>
    <deviceName>Treponema Pallidum Antibody (anti-TP) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4201323</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:48:20.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBX-017QH</udiDi>
    <basicUdiDi>B-EBX-017QH</basicUdiDi>
    <tradeName>EurobioPlex Coxiella Burnetii</tradeName>
    <deviceName>EurobioPlex Coxiella burnetii</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011603</emdnCode>
    <emdnDescription>COXIELLA BURNETII (Q FEVER) - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-017</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:32:19.383Z</lastUpdated>
  </row>
</eudamedExport>