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    <tradeName>PlexPCR Colour Compensation</tradeName>
    <deviceName>PlexPCR Colour Compensation</deviceName>
    <manufacturerName>SpeeDx Pty. Ltd.</manufacturerName>
    <manufacturerSrn>AU-MF-000016649</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080908</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR ALL INFECTIONS/ NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:07:11.987Z</lastUpdated>
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    <udiDi>15420045514577</udiDi>
    <basicUdiDi>54200455DIAGAPTCMVAP</basicUdiDi>
    <tradeName>Aptima CMV Quant Assay Calibrator</tradeName>
    <deviceName>Aptima CMV Quant Assay</deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080908</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR ALL INFECTIONS/ NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-05075</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:06:35.791Z</lastUpdated>
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    <udiDi>15099590745134</udiDi>
    <basicUdiDi>150995901C39448SE</basicUdiDi>
    <tradeName>Access anti-HAV IgM Calibrator</tradeName>
    <deviceName>Access anti-HAV IgM Calibrator</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080902</emdnCode>
    <emdnDescription>HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C39448</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:40:00.704Z</lastUpdated>
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    <udiDi>15099590745103</udiDi>
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    <tradeName>Access anti-HAV Calibrator</tradeName>
    <deviceName>Access anti-HAV Calibrator</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080902</emdnCode>
    <emdnDescription>HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C39445</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:40.636Z</lastUpdated>
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    <udiDi>07613336224908</udiDi>
    <basicUdiDi>761333602953BM</basicUdiDi>
    <tradeName>IGRA TB CS Elecsys</tradeName>
    <deviceName>CalSet IGRA TB</deviceName>
    <manufacturerName>Roche Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006260</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080901</emdnCode>
    <emdnDescription>BACTERIOLOGY STANDARDS AND CALIBRATORS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09989960190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:50:24.387Z</lastUpdated>
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    <udiDi>06975577177049</udiDi>
    <basicUdiDi>697015090000276HT</basicUdiDi>
    <tradeName>AutoLumo B19 IgM Calibrators</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080904</emdnCode>
    <emdnDescription>OTHER VIROLOGY STANDARDS AND CALIBRATORS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA170201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:16:17.732Z</lastUpdated>
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    <udiDi>06975577177018</udiDi>
    <basicUdiDi>697015090000275HR</basicUdiDi>
    <tradeName>AutoLumo B19 IgG Calibrators</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080904</emdnCode>
    <emdnDescription>OTHER VIROLOGY STANDARDS AND CALIBRATORS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA170101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:16:16.568Z</lastUpdated>
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    <udiDi>06937287300179</udiDi>
    <basicUdiDi>B-06937287300179</basicUdiDi>
    <tradeName>06937287300179</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen AmTech Bioengineering Ltd., Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000043067</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105080907</emdnCode>
    <emdnDescription>MULTICONSTITUENT STANDARDS AND CALIBRATORS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6×1 mL (6 levels)</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:51:27.597Z</lastUpdated>
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