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    <tradeName>VIASURE H. pylori + Clarithromycin resistance Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>H. PYLORI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:13:50.051Z</lastUpdated>
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    <udiDi>08435440221593</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CLAPW</basicUdiDi>
    <tradeName>VIASURE H. pylori + Clarithromycin resistance Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
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    <lastUpdated>2026-07-29T06:13:44.661Z</lastUpdated>
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    <udiDi>08435440221609</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_CLAPW</basicUdiDi>
    <tradeName>VIASURE H. pylori + Clarithromycin resistance Real Time PCR Detection Kit</tradeName>
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    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
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    <emdnDescription>H. PYLORI DETECTION BY NA REAGENTS</emdnDescription>
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    <udiDi>08056771104388</udiDi>
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    <tradeName>LIAISON® QuantiFERON®-TB Gold Plus II</tradeName>
    <deviceName>LIAISON® QuantiFERON®-TB Gold Plus II</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>311090</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-28T00:40:10.629Z</lastUpdated>
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    <udiDi>08056771101097</udiDi>
    <basicUdiDi>80567713108804W</basicUdiDi>
    <tradeName>LIAISON® Borrelia IgG</tradeName>
    <deviceName>LIAISON® Borrelia IgG</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010603</emdnCode>
    <emdnDescription>LYME ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>310880</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-28T00:39:45.018Z</lastUpdated>
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    <udiDi>08056771100748</udiDi>
    <basicUdiDi>80567713105804F</basicUdiDi>
    <tradeName>LIAISON® Chlamydia trachomatis IgA</tradeName>
    <deviceName>LIAISON® Chlamydia trachomatis IgA</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010109</emdnCode>
    <emdnDescription>CHLAMYDIA TRACHOMATIS ANTIBODY IGA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>310580</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-28T00:39:36.218Z</lastUpdated>
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    <udiDi>08056771100724</udiDi>
    <basicUdiDi>80567713105704C</basicUdiDi>
    <tradeName>LIAISON® Chlamydia trachomatis IgG</tradeName>
    <deviceName>LIAISON® Chlamydia trachomatis IgG</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010110</emdnCode>
    <emdnDescription>CHLAMYDIA TRACHOMATIS ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>310570</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-28T00:39:33.809Z</lastUpdated>
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    <udiDi>08056771100038</udiDi>
    <basicUdiDi>805677131002034</basicUdiDi>
    <tradeName>LIAISON® Borrelia IgM Quant</tradeName>
    <deviceName>LIAISON® Borrelia IgM Quant</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010604</emdnCode>
    <emdnDescription>LYME ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>310020</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-28T00:39:14.602Z</lastUpdated>
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    <udiDi>08056771100007</udiDi>
    <basicUdiDi>80567713100102Z</basicUdiDi>
    <tradeName>LIAISON® Borrelia IgM II</tradeName>
    <deviceName>LIAISON® Borrelia IgM II</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010604</emdnCode>
    <emdnDescription>LYME ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>310010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-28T00:39:09.798Z</lastUpdated>
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    <udiDi>D-IBA-402JX</udiDi>
    <basicUdiDi>B-IBA-402JX</basicUdiDi>
    <tradeName>Brucella Abortus Antigen Rapid Test Cassette</tradeName>
    <deviceName>Brucella Abortus Antigen Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011701</emdnCode>
    <emdnDescription>BRUCELLA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IBA-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-27T22:05:27.606Z</lastUpdated>
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    <udiDi>08431673231330</udiDi>
    <basicUdiDi>B-08431673231330</basicUdiDi>
    <tradeName>RPR-CARBON</tradeName>
    <deviceName>Rapid plasma reagin</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010306</emdnCode>
    <emdnDescription>SYPHILIS, REAGIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23133</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:45:17.404Z</lastUpdated>
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    <udiDi>08431673204082</udiDi>
    <basicUdiDi>B-08431673204082</basicUdiDi>
    <tradeName>TPHA</tradeName>
    <deviceName>Treponema pallidum haemagglutination</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1200408</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:44:37.307Z</lastUpdated>
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    <udiDi>08431673204068</udiDi>
    <basicUdiDi>B-08431673204068</basicUdiDi>
    <tradeName>VDRL</tradeName>
    <deviceName>Venereal disease research laboratory</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010306</emdnCode>
    <emdnDescription>SYPHILIS, REAGIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1200406</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:44:33.295Z</lastUpdated>
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    <udiDi>08431673204051</udiDi>
    <basicUdiDi>B-08431673204051</basicUdiDi>
    <tradeName>VDRL</tradeName>
    <deviceName>Venereal disease research laboratory</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010306</emdnCode>
    <emdnDescription>SYPHILIS, REAGIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1200405</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:44:32.499Z</lastUpdated>
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    <udiDi>08431673204020</udiDi>
    <basicUdiDi>B-08431673204020</basicUdiDi>
    <tradeName>RPR-CARBON</tradeName>
    <deviceName>Rapid plasma reagin</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>SYPHILIS, REAGIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1200402</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:44:31.701Z</lastUpdated>
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    <udiDi>08431673204013</udiDi>
    <basicUdiDi>B-08431673204013</basicUdiDi>
    <tradeName>RPR-CARBON</tradeName>
    <deviceName>Rapid plasma reagin</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0105010306</emdnCode>
    <emdnDescription>SYPHILIS, REAGIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1200401</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:44:30.900Z</lastUpdated>
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    <udiDi>08431673001889</udiDi>
    <basicUdiDi>B-08431673001889</basicUdiDi>
    <tradeName>RPR-CARBON</tradeName>
    <deviceName>Rapid plasma reagin</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>SYPHILIS, REAGIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40131</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:41:22.514Z</lastUpdated>
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    <udiDi>08431673001872</udiDi>
    <basicUdiDi>B-08431673001872</basicUdiDi>
    <tradeName>RPR-CARBON</tradeName>
    <deviceName>Rapid plasma reagin</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>SYPHILIS, REAGIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-27T21:41:21.700Z</lastUpdated>
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    <udiDi>D-IMPM-402LX</udiDi>
    <basicUdiDi>B-IMPM-402LX</basicUdiDi>
    <tradeName>Mycoplasma Pneumoniae IgM Rapid Test Cassette</tradeName>
    <deviceName>Mycoplasma Pneumoniae IgM Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMPM-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:37:00.695Z</lastUpdated>
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    <udiDi>D-IMP-502UQ</udiDi>
    <basicUdiDi>B-IMP-502UQ</basicUdiDi>
    <tradeName>Mycoplasma pneumoniae Antigen Rapid Test Cassette</tradeName>
    <deviceName>Mycoplasma pneumoniae Antigen Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010801</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMP-502</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:36:59.895Z</lastUpdated>
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