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    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080107</emdnCode>
    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>543655</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:03:01.407Z</lastUpdated>
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    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:03:00.618Z</lastUpdated>
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    <manufacturerName>bioMérieux, Inc.</manufacturerName>
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    <emdnDescription>GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
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    <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>543643</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:02:58.027Z</lastUpdated>
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    <tradeName>VITEK® 2 AST-XN38</tradeName>
    <deviceName>VITEK® 2 AST-XN38</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080107</emdnCode>
    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>543644</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:02:55.822Z</lastUpdated>
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    <tradeName>VITEK® 2 AST-N477</tradeName>
    <deviceName>VITEK® 2 AST-N477</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080107</emdnCode>
    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:02:54.204Z</lastUpdated>
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    <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>543628</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:02:51.927Z</lastUpdated>
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    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
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    <emdnDescription>GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>543572</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:02:38.136Z</lastUpdated>
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    <tradeName>VITEK® 2 AST-N476</tradeName>
    <deviceName>VITEK® 2 AST-N476</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080107</emdnCode>
    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>543571</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:02:35.752Z</lastUpdated>
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    <udiDi>03573026639020</udiDi>
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    <tradeName>VITEK® 2 AST-N475</tradeName>
    <deviceName>VITEK® 2 AST-N475</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080107</emdnCode>
    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>543564</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:02:34.139Z</lastUpdated>
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    <udiDi>03573026638726</udiDi>
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    <tradeName>VITEK® 2 AST-N471</tradeName>
    <deviceName>VITEK® 2 AST-N471</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080107</emdnCode>
    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>543551</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:02:33.337Z</lastUpdated>
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    <udiDi>03573026638702</udiDi>
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    <tradeName>VITEK® 2 AST-N470</tradeName>
    <deviceName>VITEK® 2 AST-N470</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080107</emdnCode>
    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>543550</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:02:31.747Z</lastUpdated>
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    <udiDi>03573026638535</udiDi>
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    <tradeName>VITEK® 2 AST-XN36</tradeName>
    <deviceName>VITEK® 2 AST-XN36</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080107</emdnCode>
    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>543543</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:02:29.348Z</lastUpdated>
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    <udiDi>03573026638511</udiDi>
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    <tradeName>VITEK® 2 AST-N469</tradeName>
    <deviceName>VITEK® 2 AST-N469</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080107</emdnCode>
    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>543542</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:02:27.750Z</lastUpdated>
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    <tradeName>VITEK® 2 AST-N468</tradeName>
    <deviceName>VITEK® 2 AST-N468</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
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    <emdnCode>W0104080107</emdnCode>
    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>543541</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:02:26.936Z</lastUpdated>
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    <deviceName>VITEK® 2 AST-N467</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>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>543540</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:02:25.342Z</lastUpdated>
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    <deviceName>VITEK® 2 AST-P670</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
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    <emdnDescription>GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>543539</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:02:23.268Z</lastUpdated>
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    <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>543532</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:02:20.529Z</lastUpdated>
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    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080107</emdnCode>
    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>543530</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:02:19.036Z</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>543529</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:02:17.741Z</lastUpdated>
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