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    <deviceName>BACT/ALERT® 3D LEFT INCUBATION MODULE</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
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    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
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    <lastUpdated>2026-07-21T21:45:54.232Z</lastUpdated>
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    <tradeName>BACT/ALERT® 3D CONTROL MODULE</tradeName>
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    <deviceName>BACT/ALERT® 3D LEFT COMBINATION MODULE</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
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    <tradeName>BACT/ALERT® 3D RIGHT COMBINATION MODULE</tradeName>
    <deviceName>BACT/ALERT® 3D RIGHT COMBINATION MODULE</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
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    <emdnDescription>AUTOMATED BLOOD CULTURE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:45:48.622Z</lastUpdated>
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    <basicUdiDi>357302BUDI002282TW</basicUdiDi>
    <tradeName>VITEK® 2 AST-XN24</tradeName>
    <deviceName>VITEK® 2 AST-XN24</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
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    <emdnCode>W0104080107</emdnCode>
    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>543242</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:52:48.401Z</lastUpdated>
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    <tradeName>VITEK® 2 AST-N428</tradeName>
    <deviceName>VITEK® 2 AST-N428</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
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    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
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    <tradeName>VITEK® MI-TUBE COLLAR</tradeName>
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    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
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    <emdnDescription>MASS - SPECTROMETRY SYSTEM</emdnDescription>
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    <reference>424180</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:52:43.603Z</lastUpdated>
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    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
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    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:52:42.009Z</lastUpdated>
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    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080107</emdnCode>
    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>542951</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:52:37.199Z</lastUpdated>
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    <tradeName>VITEK® 2 AST-N415</tradeName>
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    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
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    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>542942</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:52:36.400Z</lastUpdated>
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    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
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    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>542933</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:52:35.596Z</lastUpdated>
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    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
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    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:52:34.799Z</lastUpdated>
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    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
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    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:52:30.792Z</lastUpdated>
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    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
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    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:52:29.188Z</lastUpdated>
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    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
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    <lastUpdated>2026-07-21T19:52:24.394Z</lastUpdated>
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    <lastUpdated>2026-07-21T19:52:23.590Z</lastUpdated>
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    <manufacturerName>bioMérieux, Inc.</manufacturerName>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:51:59.544Z</lastUpdated>
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    <manufacturerName>bioMérieux, Inc.</manufacturerName>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:51:53.939Z</lastUpdated>
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