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    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <lastUpdated>2026-07-15T20:35:04.236Z</lastUpdated>
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    <tradeName>Phoenix</tradeName>
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    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
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    <udiDi>00382904484200</udiDi>
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    <deviceName>BD Phoenix™ PMIC-84</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
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    <emdnDescription>GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
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    <lastUpdated>2026-07-15T20:34:59.447Z</lastUpdated>
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    <udiDi>30382904495801</udiDi>
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    <tradeName>Phoenix</tradeName>
    <deviceName>BD Phoenix™ UNMIC/ID-471</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
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    <emdnDescription>COMBINED SUSCEPTIBILITY AND IDENTIFICATION SYSTEMS GRAM NEGATIVES - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>449580</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:31:05.347Z</lastUpdated>
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    <udiDi>30382904487943</udiDi>
    <basicUdiDi>038290BJBIMPEVZJ</basicUdiDi>
    <tradeName>Phoenix</tradeName>
    <deviceName>BD Phoenix™ NMIC/ID-402</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080109</emdnCode>
    <emdnDescription>COMBINED SUSCEPTIBILITY AND IDENTIFICATION SYSTEMS GRAM NEGATIVES - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>448794</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:31:04.582Z</lastUpdated>
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    <udiDi>00382904486143</udiDi>
    <basicUdiDi>038290AZIKCIZIAX</basicUdiDi>
    <tradeName>Phoenix</tradeName>
    <deviceName>BD Phoenix™ PMIC/ID-95</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080110</emdnCode>
    <emdnDescription>COMBINED SUSCEPTIBILITY AND IDENTIFICATION SYSTEMS GRAM POSITIVES - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>448614</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:27:29.014Z</lastUpdated>
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    <udiDi>D-PartNumberC79388AK</udiDi>
    <basicUdiDi>B-PartNumberC79388AK</basicUdiDi>
    <tradeName>MicroScan Neg Combo 96</tradeName>
    <deviceName>MicroScan Neg Combo 96</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>C79388</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:22:19.662Z</lastUpdated>
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    <tradeName>MicroScan Neg Combo 94</tradeName>
    <deviceName>MicroScan Neg Combo 94</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>GRAM NEGATIVE IDENTIFICATION - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-15T02:12:24.966Z</lastUpdated>
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    <udiDi>D-C79389Y6</udiDi>
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    <tradeName>MicroScan Neg Combo 97</tradeName>
    <deviceName>MicroScan Neg Combo 97</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>GRAM NEGATIVE IDENTIFICATION - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C79389</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:07.531Z</lastUpdated>
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    <udiDi>D-C79387Y2</udiDi>
    <basicUdiDi>B-C79387Y2</basicUdiDi>
    <tradeName>MicroScan Neg Urine Combo 95</tradeName>
    <deviceName>MicroScan Neg Urine Combo 95</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080101</emdnCode>
    <emdnDescription>GRAM NEGATIVE IDENTIFICATION - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C79387</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:06.734Z</lastUpdated>
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    <udiDi>D-C63726WD</udiDi>
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    <tradeName>MicroScan Neg MIC 61</tradeName>
    <deviceName>MicroScan Neg MIC 61</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>GRAM NEGATIVE IDENTIFICATION - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C63726</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:01.127Z</lastUpdated>
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    <tradeName>MicroScan Neg MIC 57</tradeName>
    <deviceName>MicroScan Neg MIC 57</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>GRAM NEGATIVE IDENTIFICATION - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C58012</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:00.328Z</lastUpdated>
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    <udiDi>08800044300065</udiDi>
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    <tradeName>QMAC-dRAST</tradeName>
    <deviceName>QMAC-dRAST GN S17, QMAC-dRAST GP S17, QMAC-dRAST GN E19, QMAC-dRAST GP E19, QMAC-dRAST GN E22</deviceName>
    <manufacturerName>QuantaMatrix Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022784</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:26:48.834Z</lastUpdated>
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    <tradeName>Gram Positive bacteria  ID</tradeName>
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    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <emdnDescription>GRAM POSITIVE IDENTIFICATION - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME0502</reference>
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    <tradeName>Gram Positive bacteria  ID</tradeName>
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    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
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    <tradeName>Gram Positive bacteria  ID</tradeName>
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    <tradeName>Gram Negative bacteria ID</tradeName>
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    <tradeName>Gram Negative bacteria ID</tradeName>
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    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
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