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    <tradeName>LyoSens™</tradeName>
    <deviceName>Viral Meningitis Genotyping qPCR Kit</deviceName>
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    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
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    <basicUdiDi>868521452PCR99JQ</basicUdiDi>
    <tradeName>ChainFor™</tradeName>
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    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <reference>CFP99P50</reference>
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    <udiDi>08685214525949</udiDi>
    <basicUdiDi>868521452PCR99JQ</basicUdiDi>
    <tradeName>ChainFor™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP99P100</reference>
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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>
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    <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>D-MME-14ETX</udiDi>
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    <deviceName>Meningitis/Encephalitis (ME) Pathogens Multiplex Detection Kit</deviceName>
    <manufacturerName>Hysen Biotech.Inc</manufacturerName>
    <manufacturerSrn>KR-MF-000048224</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>MME-14E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:09:48.263Z</lastUpdated>
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    <udiDi>08435440207917</udiDi>
    <basicUdiDi>84354402_MDXMENIN_HNSZ7</basicUdiDi>
    <tradeName>VIASURE H. influenzae, N. meningitidis &amp; S. pneumoniae Real Time PCR Detection Kit</tradeName>
    <deviceName>VIASURE H. influenzae, N. meningitidis &amp; S. pneumoniae Real Time PCR Detection Kit</deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-HNS106L</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:19:37.908Z</lastUpdated>
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    <udiDi>D-G2M803821G5</udiDi>
    <basicUdiDi>B-G2M803821G5</basicUdiDi>
    <tradeName>MCP-Q comprehensive Real Time PCR Kit for Meningitis</tradeName>
    <deviceName>MCP-Q comprehensive Real Time PCR Kit for Meningitis</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>W0105070505</emdnCode>
    <emdnDescription>MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M803821,G2M803821R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:45:19.597Z</lastUpdated>
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    <udiDi>D-EBX-022-36BX</udiDi>
    <basicUdiDi>B-EBX-022-36BX</basicUdiDi>
    <tradeName>EurobioPlex Méningite bactérienne materno-foetale</tradeName>
    <deviceName>EurobioPlex Méningite bactérienne materno-foetale</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070505</emdnCode>
    <emdnDescription>MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-022-36</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:32:31.392Z</lastUpdated>
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    <udiDi>D-EBX-022-09BU</udiDi>
    <basicUdiDi>B-EBX-022-09BU</basicUdiDi>
    <tradeName>EurobioPlex Méningite bactérienne materno-foetale</tradeName>
    <deviceName>EurobioPlex Méningite bactérienne materno-foetale</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
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    <udiDi>D-EBX-020-36BH</udiDi>
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    <tradeName>EurobioPlex Méningite bactérienne communautaire</tradeName>
    <deviceName>EurobioPlex Méningite bactérienne communautaire</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
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    <udiDi>D-EBX-020-09BE</udiDi>
    <basicUdiDi>B-EBX-020-09BE</basicUdiDi>
    <tradeName>EurobioPlex Méningite bactérienne communautaire</tradeName>
    <deviceName>EurobioPlex Méningite bactérienne communautaire</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
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    <tradeName>RIDA®Plex CSF 16 well Step 1</tradeName>
    <deviceName>RIDA®Plex CSF 16 well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>RIDA®Plex CSF 16 well Step 2</tradeName>
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    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>CSF 16-well</tradeName>
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    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
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    <tradeName>CSF 16-well</tradeName>
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    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
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    <tradeName>Allplex™ Meningitis-B Assay</tradeName>
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    <manufacturerName>Seegene, Inc.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Allplex™ Meningitis-V2 Assay</tradeName>
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    <manufacturerName>Seegene, Inc.</manufacturerName>
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