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    <tradeName>System Check Solution</tradeName>
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    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
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    <tradeName>System Check Solution</tradeName>
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    <tradeName>Rinsing Solution</tradeName>
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    <tradeName>Equilibration Reagent 2</tradeName>
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    <basicUdiDi>B-04250317533135</basicUdiDi>
    <tradeName>Reconstitution Buffer</tradeName>
    <deviceName>Reconstitution Buffer</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
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    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
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    <tradeName>Extraction Buffer</tradeName>
    <deviceName>Extraction Buffer</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
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    <udiDi>04250317533081</udiDi>
    <basicUdiDi>B-04250317533081</basicUdiDi>
    <tradeName>Mobile Phase B</tradeName>
    <deviceName>Mobile Phase B</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
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    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
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    <tradeName>MassTox® TDM Series A PARAMETER-Set  Antiarrhythmic Drugs in Serum/Plasma</tradeName>
    <deviceName>MassTox® TDM Series A PARAMETER Set Antiarrhythmic Drugs in Serum/Plasma</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
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    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
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    <tradeName>Tuning Mix</tradeName>
    <deviceName>Tuning Mix</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
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    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <udiDi>04250317526649</udiDi>
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    <tradeName>MassCheck® Antiarrythmic Drugs Plasma Control, Bi-Level (I + II)</tradeName>
    <deviceName>MassCheck® Antiarrythmic Drugs Plasma Control, Bi-Level (I + II)</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:44:15.445Z</lastUpdated>
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    <tradeName>MassCheck® Antiarrythmic Drugs Plasma Control, Level II</tradeName>
    <deviceName>MassCheck® Antiarrythmic Drugs Plasma Control, Level II</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>04250317526625</udiDi>
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    <tradeName>MassCheck® Antiarrythmic Drugs Plasma Control, Level I</tradeName>
    <deviceName>MassCheck® Antiarrythmic Drugs Plasma Control, Level I</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
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    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>04250317526618</udiDi>
    <basicUdiDi>B-04250317526618</basicUdiDi>
    <tradeName>Internal Standard Mix</tradeName>
    <deviceName>Internal Standard Mix</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
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    <tradeName>3PLUS1® Multilevel Plasma Calibrator Set</tradeName>
    <deviceName>3PLUS1® Multilevel Plasma Calibrator Set</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
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    <tradeName>LC-MS/MS Reagent Kit MassChrom® Methylmalonic Acid in plasma/ serum/urine</tradeName>
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    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
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    <tradeName>MassCheck® Methylmalonic Acid Urine Control Bi-Level (I+II)</tradeName>
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    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
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    <tradeName>MassCheck® Methylmalonic Acid Urine Control Level II</tradeName>
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    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
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    <tradeName>MassCheck® Methylmalonic Acid Urine Control Level I</tradeName>
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    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
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    <tradeName>MassCheck® Methylmalonic Acid Plasma Control Level II</tradeName>
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    <tradeName>MassCheck® Methylmalonic Acid Plasma Control Level I</tradeName>
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    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
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