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    <tradeName>ETEST® Moxifloxacin (MX)</tradeName>
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    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:57:41.336Z</lastUpdated>
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    <tradeName>ETEST® Quinupristin/Dalfopristin (QDA)</tradeName>
    <deviceName>ETEST® Quinupristin/Dalfopristin (QDA)</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
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    <tradeName>ETEST® Trimethoprim (TR)</tradeName>
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    <manufacturerName>bioMérieux SA</manufacturerName>
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    <tradeName>ETEST® Piperacillin (PP)</tradeName>
    <deviceName>ETEST® Piperacillin (PP)</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8308984</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:57:34.505Z</lastUpdated>
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    <udiDi>03573026550257</udiDi>
    <basicUdiDi>357302BUDI000752TY</basicUdiDi>
    <tradeName>ETEST® Oxacillin (OX)</tradeName>
    <deviceName>ETEST® Oxacillin (OX)</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8308982</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:57:33.702Z</lastUpdated>
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    <basicUdiDi>357302BUDI000794UG</basicUdiDi>
    <tradeName>ETEST® Ofloxacin (OF)</tradeName>
    <deviceName>ETEST® Ofloxacin (OF)</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
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    <emdnCode>W0104080501</emdnCode>
    <emdnDescription>MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:57:28.912Z</lastUpdated>
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    <tradeName>RAPIDEC® CARBA NP</tradeName>
    <deviceName>RAPIDEC® CARBA NP</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0104080506</emdnCode>
    <emdnDescription>TARGETED RESISTANCE TESTS - CARBAPENEMASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>415418</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:57:20.895Z</lastUpdated>
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    <tradeName>VITEK® 2 AST-N421</tradeName>
    <deviceName>VITEK® 2 AST-N421</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
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    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:55:44.114Z</lastUpdated>
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    <tradeName>ETEST® Mecillinam (MM)</tradeName>
    <deviceName>ETEST® Mecillinam (MM)</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
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    <emdnCode>W0104080501</emdnCode>
    <emdnDescription>MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>543055</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:55:43.310Z</lastUpdated>
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    <udiDi>03573026624835</udiDi>
    <basicUdiDi>357302BUDI000696UF</basicUdiDi>
    <tradeName>ETEST® Gentamicin (GM)</tradeName>
    <deviceName>ETEST® Gentamicin (GM)</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080501</emdnCode>
    <emdnDescription>MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>543030</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:55:40.907Z</lastUpdated>
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    <udiDi>03573026617363</udiDi>
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    <tradeName>VITEK® 2 AST-N404</tradeName>
    <deviceName>VITEK® 2 AST-N404</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>
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    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>542727</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:55:36.924Z</lastUpdated>
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    <udiDi>03573026616885</udiDi>
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    <tradeName>VITEK® 2 AST-P663</tradeName>
    <deviceName>VITEK® 2 AST-P663</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>W0104080108</emdnCode>
    <emdnDescription>GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>542707</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:55:35.321Z</lastUpdated>
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    <tradeName>VITEK® 2 AST-N403</tradeName>
    <deviceName>VITEK® 2 AST-N403</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>542706</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:55:34.517Z</lastUpdated>
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    <tradeName>VITEK® 2 AST-N402</tradeName>
    <deviceName>VITEK® 2 AST-N402</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>542705</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:55:32.899Z</lastUpdated>
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    <tradeName>VITEK® 2 AST-N395</tradeName>
    <deviceName>VITEK® 2 AST-N395</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
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    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>542603</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:55:26.498Z</lastUpdated>
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    <manufacturerName>bioMérieux, Inc.</manufacturerName>
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    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-30T17:55:24.109Z</lastUpdated>
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    <tradeName>XYL</tradeName>
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    <manufacturerName>bioMérieux SA</manufacturerName>
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    <emdnCode>W0104080599</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>541070</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:54:03.136Z</lastUpdated>
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    <emdnDescription>MANUAL SUSCEPTIBILITY TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:54:00.725Z</lastUpdated>
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    <tradeName>API® 50 CHB/E Medium</tradeName>
    <deviceName>API® 50 CHB/E Medium</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
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    <riskClass>IVD Sınıf B</riskClass>
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    <emdnCode>W0104080299</emdnCode>
    <emdnDescription>MANUAL IDENTIFICATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>541068</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:53:59.142Z</lastUpdated>
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    <deviceName>API® 50 CHL Medium</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>MANUAL IDENTIFICATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>541067</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:53:58.322Z</lastUpdated>
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