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    <tradeName>LC-MS/MS Reagent Kit MassTox® Immunosuppressants in whole blood ONEMINUTE Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:32:19.053Z</lastUpdated>
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    <udiDi>04250317557841</udiDi>
    <basicUdiDi>4250317930006C</basicUdiDi>
    <tradeName>LC-MS/MS Reagent Kit MassTox® Immunosuppressants in whole blood ONEMINUTE Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>04250317558046</udiDi>
    <basicUdiDi>4250317930006C</basicUdiDi>
    <tradeName>LC-MS/MS Reagent Kit MassTox® Immunosuppressants in whole blood ONEMINUTE Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
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    <emdnDescription></emdnDescription>
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    <lastUpdated>2026-09-21T20:32:18.910Z</lastUpdated>
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    <udiDi>04250317521637</udiDi>
    <basicUdiDi>4250317930006C</basicUdiDi>
    <tradeName>6PLUS1® Multilevel Whole Blood Calibrator Set</tradeName>
    <deviceName>resi IMT Inspiratory muscle trainer resi</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R900902</emdnCode>
    <emdnDescription>INSPIRATORY AND EXPIRATORY FLOW STIMULATORS/RESPIRATORY MUSCLES TRAINERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>28039/XL</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:32:18.773Z</lastUpdated>
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    <udiDi>04250317551917</udiDi>
    <basicUdiDi>4250317752226Q</basicUdiDi>
    <tradeName>LC-MS/MS-Reagent Kit MassChrom® Amino Acid Analysis in urine</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>75222</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:32:17.878Z</lastUpdated>
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    <udiDi>04250317535146</udiDi>
    <basicUdiDi>425031792912XTQX</basicUdiDi>
    <tradeName>MassTox® TDM Series A PARAMETER Set Neuroleptics 1/EXTENDED in serum/plasma</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92912/XT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:31:40.109Z</lastUpdated>
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    <udiDi>04250317535085</udiDi>
    <basicUdiDi>425031792912XTQX</basicUdiDi>
    <tradeName>MassCheck® Neuroleptics 1/EXTENDED Plasma Control Level II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
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    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0212/XT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:29:21.035Z</lastUpdated>
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    <udiDi>04250317551184</udiDi>
    <basicUdiDi>4250317752226Q</basicUdiDi>
    <tradeName>MassCheck® Amino Acid Analysis Urine Control Level III</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0476</reference>
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    <udiDi>04250317535078</udiDi>
    <basicUdiDi>425031792912XTQX</basicUdiDi>
    <tradeName>MassCheck® Neuroleptics 1/EXTENDED Plasma Control Level I</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0211/XT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:29:20.999Z</lastUpdated>
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    <udiDi>04250317551085</udiDi>
    <basicUdiDi>4250317752226Q</basicUdiDi>
    <tradeName>Internal Standard Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>75246</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:29:20.965Z</lastUpdated>
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    <udiDi>04250317548450</udiDi>
    <basicUdiDi>4250317752226Q</basicUdiDi>
    <tradeName>Collection Plates</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
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    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>75058</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:29:20.944Z</lastUpdated>
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    <udiDi>04250317535139</udiDi>
    <basicUdiDi>425031792912XTQX</basicUdiDi>
    <tradeName>3PLUS1® Multilevel Plasma Calibrator Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92028/XT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:29:20.922Z</lastUpdated>
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    <udiDi>04250317551870</udiDi>
    <basicUdiDi>4250317752226Q</basicUdiDi>
    <tradeName>Dilution Buffer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>75205</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:29:20.907Z</lastUpdated>
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    <udiDi>04250317542649</udiDi>
    <basicUdiDi>4250317752226Q</basicUdiDi>
    <tradeName>Analytical Column</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
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    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>75100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:29:20.892Z</lastUpdated>
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    <udiDi>04250317551177</udiDi>
    <basicUdiDi>4250317752226Q</basicUdiDi>
    <tradeName>MassCheck® Amino Acid Analysis Urine Control Level II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
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    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0475</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:29:20.876Z</lastUpdated>
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    <udiDi>04250317535061</udiDi>
    <basicUdiDi>425031792912XTQX</basicUdiDi>
    <tradeName>MassCheck® Neuroleptics 1/EXTENDED Plasma Control Bi-Level (I + II)</tradeName>
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    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
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    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>04250317551160</udiDi>
    <basicUdiDi>4250317752226Q</basicUdiDi>
    <tradeName>MassCheck® Amino Acid Analysis Urine Control Level I</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0474</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:29:20.836Z</lastUpdated>
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    <udiDi>04250317551931</udiDi>
    <basicUdiDi>4250317752226Q</basicUdiDi>
    <tradeName>LC-MS/MS-Reagent Kit MassChrom® Amino Acid Analysis in urine with 96 Deep Well Plates</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:29:20.813Z</lastUpdated>
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    <udiDi>04250317551894</udiDi>
    <basicUdiDi>4250317752226Q</basicUdiDi>
    <tradeName>Adjustment Reagent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>75212</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:29:20.784Z</lastUpdated>
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    <udiDi>04250317551115</udiDi>
    <basicUdiDi>4250317752226Q</basicUdiDi>
    <tradeName>3PLUS1® Multilevel Urine Calibrator Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:29:20.756Z</lastUpdated>
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