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    <tradeName>VIASURE Cryptosporidium, Giardia &amp; E. histolytica Real Time PCR Detection Kit</tradeName>
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    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
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    <tradeName>VIASURE Cryptosporidium, Giardia &amp; E. histolytica Real Time PCR Detection Kit</tradeName>
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    <tradeName>VIASURE Cryptosporidium, Giardia &amp; E. histolytica Real Time PCR Detection Kit</tradeName>
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    <tradeName>VIASURE Cryptosporidium, Giardia &amp; E. histolytica Real Time PCR Detection Kit</tradeName>
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    <basicUdiDi>84354402_MDXGASTROB_KGEQX</basicUdiDi>
    <tradeName>VIASURE Cryptosporidium, Giardia &amp; E. histolytica Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>00815381021007</udiDi>
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    <tradeName>BIOFIRE® FILMARRAY® Tropical Fever (TF) Panel</tradeName>
    <deviceName>BIOFIRE® FILMARRAY® Tropical Fever (TF) Panel</deviceName>
    <manufacturerName>BioFire Diagnostics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003311</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070506</emdnCode>
    <emdnDescription>TROPICAL FEVER - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>424803</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:53:23.338Z</lastUpdated>
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    <tradeName>BioFire® Blood Culture Identification 2 (BCID2) Panel</tradeName>
    <deviceName>BioFire® Blood Culture Identification 2 (BCID2) Panel</deviceName>
    <manufacturerName>BioFire Diagnostics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003311</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
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    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RFIT-ASY-0147</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:53:21.746Z</lastUpdated>
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    <tradeName>BioFire® Joint Infection (JI) Panel</tradeName>
    <deviceName>BioFire® Joint Infection (JI) Panel</deviceName>
    <manufacturerName>BioFire Diagnostics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003311</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RFIT-ASY-0135</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:53:20.955Z</lastUpdated>
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    <udiDi>00815381020123</udiDi>
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    <tradeName>FilmArray® Meningitis/Encephalitis (ME) Panel</tradeName>
    <deviceName>FilmArray® Meningitis/Encephalitis (ME) Panel</deviceName>
    <manufacturerName>BioFire Diagnostics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003311</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070505</emdnCode>
    <emdnDescription>MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RFIT-ASY-0118</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:53:04.877Z</lastUpdated>
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    <udiDi>00815381020116</udiDi>
    <basicUdiDi>357302BUDI000005SL</basicUdiDi>
    <tradeName>FilmArray® Gastrointestinal (GI) Panel</tradeName>
    <deviceName>FilmArray® Gastrointestinal (GI) Panel</deviceName>
    <manufacturerName>BioFire Diagnostics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003311</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RFIT-ASY-0104</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:53:04.078Z</lastUpdated>
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    <udiDi>06974318132873</udiDi>
    <basicUdiDi>697431813E-KitH4</basicUdiDi>
    <tradeName>Nucleic Acid Extraction Kit WDT-96</tradeName>
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    <manufacturerName>Wuhan MGI Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-002012-00</reference>
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    <lastUpdated>2026-07-29T11:00:12.792Z</lastUpdated>
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    <tradeName>Nucleic Acid Extraction Kit WDT-864</tradeName>
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    <manufacturerName>Wuhan MGI Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-29T11:00:12.725Z</lastUpdated>
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    <udiDi>08033891483937</udiDi>
    <basicUdiDi>803389148CMV19C8</basicUdiDi>
    <tradeName>CMV ELITe MGB® Kit</tradeName>
    <deviceName>CMV ELITe MGB® Kit</deviceName>
    <manufacturerName>ElitechGroup S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000005919</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>CMV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTK015PLD</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:50:07.471Z</lastUpdated>
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    <tradeName>Tetanus IgG Test Cassette</tradeName>
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    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <lastUpdated>2026-07-29T08:26:12.689Z</lastUpdated>
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    <tradeName>Merilisa</tradeName>
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    <emdnDescription>HIV P24 ANTIBODY</emdnDescription>
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    <reference>HV4ELI - 05</reference>
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    <lastUpdated>2026-07-29T08:24:18.155Z</lastUpdated>
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    <tradeName>Merilisa</tradeName>
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    <reference>HV4ELI – 08</reference>
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    <manufacturerSrn>IN-MF-000028158</manufacturerSrn>
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    <emdnDescription>HEPATITIS B SURFACE ANTIGEN</emdnDescription>
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    <reference>HPBELI-06</reference>
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    <lastUpdated>2026-07-29T08:15:24.305Z</lastUpdated>
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    <tradeName>BACTERIAL ANTIGENS</tradeName>
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    <manufacturerName>Spinreact S.A.U.</manufacturerName>
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    <legislation>IVDD</legislation>
    <emdnCode>W0105011701</emdnCode>
    <emdnDescription>BRUCELLA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1205006-P</reference>
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    <lastUpdated>2026-07-29T08:08:12.642Z</lastUpdated>
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    <tradeName>BACTERIAL ANTIGENS</tradeName>
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