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    <tradeName>VITROS</tradeName>
    <deviceName>VITROS 450</deviceName>
    <manufacturerName>Ortho Clinical Diagnostics Biotechnology Development (Shanghai) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000053560</manufacturerSrn>
    <authorisedRepresentativeName>Ortho-Clinical Diagnostics France</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000002720</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6204444</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:29:33.967Z</lastUpdated>
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    <udiDi>10758750036189</udiDi>
    <basicUdiDi>10758750036189MW</basicUdiDi>
    <tradeName>VITROS Chemistry Products ALBp Slides</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortho-Clinical Diagnostics, Inc. Rochester</manufacturerName>
    <manufacturerSrn>US-MF-000009352</manufacturerSrn>
    <authorisedRepresentativeName>Ortho-Clinical Diagnostics France</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000002720</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6112233</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:10:04.138Z</lastUpdated>
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    <basicUdiDi>10758750036189MW</basicUdiDi>
    <tradeName>VITROS Chemistry Products Calibrator Kit 35</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortho-Clinical Diagnostics, Inc. Rochester</manufacturerName>
    <manufacturerSrn>US-MF-000009352</manufacturerSrn>
    <authorisedRepresentativeName>Ortho-Clinical Diagnostics France</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000002720</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6811213</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:10:03.322Z</lastUpdated>
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    <basicUdiDi>10758750036189MW</basicUdiDi>
    <tradeName>VITROS Chemistry Products ALBp Slides</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortho-Clinical Diagnostics, Inc. Rochester</manufacturerName>
    <manufacturerSrn>US-MF-000009352</manufacturerSrn>
    <authorisedRepresentativeName>Ortho-Clinical Diagnostics France</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000002720</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6811212</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:09:55.641Z</lastUpdated>
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