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    <tradeName>TypeStream™ Visual Software version 3.2</tradeName>
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    <manufacturerName>One Lambda, Inc.</manufacturerName>
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    <deviceName>GeneXpert® Infinity Systems</deviceName>
    <manufacturerName>Cepheid</manufacturerName>
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    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
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    <basicUdiDi>081164701-XPERTCHECK-3B</basicUdiDi>
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    <manufacturerName>Cepheid</manufacturerName>
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    <reference>XPERTCHECK-CE-5</reference>
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    <lastUpdated>2026-07-16T01:13:25.640Z</lastUpdated>
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    <tradeName>07350148190006</tradeName>
    <deviceName>Qlucore Diagnostics Platform</deviceName>
    <manufacturerName>Qlucore AB(publ)</manufacturerName>
    <manufacturerSrn>SE-MF-000030781</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QD Platform,</reference>
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    <lastUpdated>2026-07-16T00:02:41.159Z</lastUpdated>
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    <tradeName>FOX</tradeName>
    <deviceName>BD FOX™ PCR Extraction Tubes</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>441992</reference>
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    <lastUpdated>2026-07-15T20:49:58.959Z</lastUpdated>
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    <tradeName>FOX</tradeName>
    <deviceName>BD FOX™ Extraction Tubes</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
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    <reference>441129</reference>
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    <lastUpdated>2026-07-15T20:49:58.179Z</lastUpdated>
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    <basicUdiDi>038290YMCUPXTNQ8</basicUdiDi>
    <tradeName>Not Applicable</tradeName>
    <deviceName>BD PCR Cartridge</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>437519</reference>
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    <lastUpdated>2026-07-15T20:49:54.144Z</lastUpdated>
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    <tradeName>COR</tradeName>
    <deviceName>BD COR™ GX INSTRUMENT</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
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    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>443990</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:44:06.306Z</lastUpdated>
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    <tradeName>MAX</tradeName>
    <deviceName>BD MAX™ System</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
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    <reference>441916</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:43:51.205Z</lastUpdated>
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    <tradeName>VIPER</tradeName>
    <deviceName>BD Specimen Tubes and Caps for use on the BD Viper™ System</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>441360</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:39:43.936Z</lastUpdated>
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    <tradeName>Not Applicable</tradeName>
    <deviceName>BD Pre-warm Heater</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>443159</reference>
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    <lastUpdated>2026-07-15T20:34:39.068Z</lastUpdated>
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    <tradeName>VIPER</tradeName>
    <deviceName>BD Viper™ LT System PCR Accessory Kit</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
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    <reference>442967</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:34:38.264Z</lastUpdated>
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    <tradeName>VIPER</tradeName>
    <deviceName>BD Viper™ LT System PCR Tube / Tray Kit</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
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    <lastUpdated>2026-07-15T20:34:37.749Z</lastUpdated>
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    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
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    <tradeName>PGDx elio tissue complete</tradeName>
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    <manufacturerName>Personal Genome Diagnostics, Inc.</manufacturerName>
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    <tradeName>CBC Wash Septa Clip Dx</tradeName>
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    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
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    <deviceName>Applied Biosystems™ SeqStudio™ Flex Dx Series Genetic Analyzer</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
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    <tradeName>Oncomine™ Dx Target Test User Guides and Assay Definition File</tradeName>
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    <manufacturerName>Life Technologies Corporation</manufacturerName>
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