<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-GCLEP(IgG/IgM)-402aHG8L</udiDi>
    <basicUdiDi>B-GCLEP(IgG/IgM)-402aHG8L</basicUdiDi>
    <tradeName>Leptospira IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Leptospira 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>W0105011704</emdnCode>
    <emdnDescription>LEPTOSPIRA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCLEP(IgG/IgM)-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:28:52.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GCCRE-T1402a25</udiDi>
    <basicUdiDi>B-GCCRE-T1402a25</basicUdiDi>
    <tradeName>CARBA 5 In 1 Rapid Test Cassette</tradeName>
    <deviceName>CARBA 5 In 1 Rapid Test Cassette</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>W0105011799</emdnCode>
    <emdnDescription>BACTERIOLOGY IMMUNOASSAY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCCRE-T1402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:25:27.915Z</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-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-Brucella-NY</udiDi>
    <basicUdiDi>B-Brucella-NY</basicUdiDi>
    <tradeName>Brucella</tradeName>
    <deviceName>Brucella</deviceName>
    <manufacturerName>NS BIOTEC</manufacturerName>
    <manufacturerSrn>EG-MF-000032515</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>Artık piyasada değil</deviceStatus>
    <reference>Brob-Ma-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:32:13.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060313275304</udiDi>
    <basicUdiDi>B-86060313275304</basicUdiDi>
    <tradeName>Verotoxin 1+2</tradeName>
    <deviceName>Verotoxin 1+2</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011799</emdnCode>
    <emdnDescription>BACTERIOLOGY IMMUNOASSAY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C1810V24VERT</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:15:04.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-084360388188182HZ</udiDi>
    <basicUdiDi>B-084360388188182HZ</basicUdiDi>
    <tradeName>Proteus OX2, 1 x 5 mL</tradeName>
    <deviceName>Proteus OX2, 1 x 5 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011712</emdnCode>
    <emdnDescription>PROTEUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0636</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:33:09.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-084360388178175HR</udiDi>
    <basicUdiDi>B-084360388178175HR</basicUdiDi>
    <tradeName>Proteus OXK, 1 x 5 mL</tradeName>
    <deviceName>Proteus OXK, 1 x 5 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011712</emdnCode>
    <emdnDescription>PROTEUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0635</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:33:08.191Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-084360388168168HH</udiDi>
    <basicUdiDi>B-084360388168168HH</basicUdiDi>
    <tradeName>Proteus OX19, 1 x 5 mL</tradeName>
    <deviceName>Proteus OX19, 1 x 5 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011712</emdnCode>
    <emdnDescription>PROTEUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0634</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:33:05.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-084360387987984MV</udiDi>
    <basicUdiDi>B-084360387987984MV</basicUdiDi>
    <tradeName>Brucella mellitensis, 1 x 5 mL</tradeName>
    <deviceName>Brucella mellitensis, 1 x 5 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011701</emdnCode>
    <emdnDescription>BRUCELLA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0616</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:32:36.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-084360387977977MM</udiDi>
    <basicUdiDi>B-084360387977977MM</basicUdiDi>
    <tradeName>Brucella abortus, 1 x 5 mL</tradeName>
    <deviceName>Brucella abortus, 1 x 5 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011701</emdnCode>
    <emdnDescription>BRUCELLA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0615</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:32:35.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-084360387397395JZ</udiDi>
    <basicUdiDi>B-084360387397395JZ</basicUdiDi>
    <tradeName>Rose Bengal, 100 tests</tradeName>
    <deviceName>Rose Bengal, 100 tests</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011701</emdnCode>
    <emdnDescription>BRUCELLA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0545</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:31:58.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-084360386316313EM</udiDi>
    <basicUdiDi>B-084360386316313EM</basicUdiDi>
    <tradeName>Agglutination slide and tube tests with positive and negative controls, 8 x 5 mL, 2 x 1 mL</tradeName>
    <deviceName>Agglutination slide and tube tests with positive and negative controls, 8 x 5 mL, 2 x 1 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011799</emdnCode>
    <emdnDescription>BACTERIOLOGY IMMUNOASSAY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0424</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:30:55.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-084360385345348FH</udiDi>
    <basicUdiDi>B-084360385345348FH</basicUdiDi>
    <tradeName>Proteus OXK, 20 x 5 mL</tradeName>
    <deviceName>Proteus OXK, 20 x 5 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011712</emdnCode>
    <emdnDescription>PROTEUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0072</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:29:02.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-084360385335331EM</udiDi>
    <basicUdiDi>B-084360385335331EM</basicUdiDi>
    <tradeName>Proteus OX2, 20 x 5 mL</tradeName>
    <deviceName>Proteus OX2, 20 x 5 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011712</emdnCode>
    <emdnDescription>PROTEUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0071</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:29:00.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-084360385325324ED</udiDi>
    <basicUdiDi>B-084360385325324ED</basicUdiDi>
    <tradeName>Proteus OX19, 20 x 5 mL</tradeName>
    <deviceName>Proteus OX19, 20 x 5 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011712</emdnCode>
    <emdnDescription>PROTEUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0070</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:28:59.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-084360385235235EB</udiDi>
    <basicUdiDi>B-084360385235235EB</basicUdiDi>
    <tradeName>Brucella mellitensis, 20 x 5 mL</tradeName>
    <deviceName>Brucella mellitensis, 20 x 5 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011701</emdnCode>
    <emdnDescription>BRUCELLA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0061</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:28:32.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-084360385225228E3</udiDi>
    <basicUdiDi>B-084360385225228E3</basicUdiDi>
    <tradeName>Brucella abortus, 20 x 5 mL</tradeName>
    <deviceName>Brucella abortus, 20 x 5 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011701</emdnCode>
    <emdnDescription>BRUCELLA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0060</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:28:31.755Z</lastUpdated>
  </row>
</eudamedExport>