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    <tradeName>Internal Standard</tradeName>
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    <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>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:41:02.449Z</lastUpdated>
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    <udiDi>04250317514486</udiDi>
    <basicUdiDi>B-04250317514486</basicUdiDi>
    <tradeName>Plasma Calibration Standard</tradeName>
    <deviceName>Plasma Calibration Standard</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <basicUdiDi>B-04250317514479</basicUdiDi>
    <tradeName>Mobile Phase</tradeName>
    <deviceName>Mobile Phase</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:40:57.053Z</lastUpdated>
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    <udiDi>04250317514455</udiDi>
    <basicUdiDi>B-04250317514455</basicUdiDi>
    <tradeName>Mobile Phase</tradeName>
    <deviceName>Mobile Phase</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>68001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:40:55.938Z</lastUpdated>
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    <udiDi>04250317514424</udiDi>
    <basicUdiDi>B-04250317514424</basicUdiDi>
    <tradeName>HPLC Reagent Kit Coenzyme Q10 in Serum/Plasma/Whole Blood</tradeName>
    <deviceName>Coenzyme Q10 in Serum/Plasma/Whole Blood</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>68000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:40:55.249Z</lastUpdated>
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    <udiDi>04250317513946</udiDi>
    <basicUdiDi>B-04250317513946</basicUdiDi>
    <tradeName>HPLC Column</tradeName>
    <deviceName>HPLC Column</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>65100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:40:54.680Z</lastUpdated>
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    <udiDi>04250317513885</udiDi>
    <basicUdiDi>B-04250317513885</basicUdiDi>
    <tradeName>Plasma Calibration Standard</tradeName>
    <deviceName>Plasma Calibration Standard</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>65003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:40:51.947Z</lastUpdated>
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    <udiDi>04250317513878</udiDi>
    <basicUdiDi>B-04250317513878</basicUdiDi>
    <tradeName>Mobile Phase</tradeName>
    <deviceName>Mobile Phase</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>65002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:40:50.716Z</lastUpdated>
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    <udiDi>04250317513854</udiDi>
    <basicUdiDi>B-04250317513854</basicUdiDi>
    <tradeName>Mobile Phase</tradeName>
    <deviceName>Mobile Phase</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>65001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:40:49.708Z</lastUpdated>
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    <udiDi>04250317513809</udiDi>
    <basicUdiDi>B-04250317513809</basicUdiDi>
    <tradeName>Analytical Column</tradeName>
    <deviceName>Analytical Column</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>64100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:40:47.523Z</lastUpdated>
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    <udiDi>04250317513694</udiDi>
    <basicUdiDi>B-04250317513694</basicUdiDi>
    <tradeName>Serum Control, Bi-Level (I + II)</tradeName>
    <deviceName>Serum 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>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0063</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:38:45.421Z</lastUpdated>
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    <udiDi>04250317513793</udiDi>
    <basicUdiDi>B-04250317513793</basicUdiDi>
    <tradeName>Clean-Up Tubes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>64008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:38:43.831Z</lastUpdated>
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    <udiDi>04250317513748</udiDi>
    <basicUdiDi>B-04250317513748</basicUdiDi>
    <tradeName>Serum Control, Bi-Level (I + II)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0064</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:38:43.132Z</lastUpdated>
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    <udiDi>04250317513670</udiDi>
    <basicUdiDi>B-04250317513670</basicUdiDi>
    <tradeName>Alprazolam, Trazodone Plasma Control Level II</tradeName>
    <deviceName>Alprazolam, Trazodone Plasma Control Level II</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0062/2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:38:42.775Z</lastUpdated>
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    <udiDi>04250317513656</udiDi>
    <basicUdiDi>B-04250317513656</basicUdiDi>
    <tradeName>Alprazolam, Trazodone Plasma Control Level I</tradeName>
    <deviceName>Alprazolam, Trazodone Plasma Control Level I</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0062/1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:38:41.049Z</lastUpdated>
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    <udiDi>04250317513649</udiDi>
    <basicUdiDi>B-04250317513649</basicUdiDi>
    <tradeName>Alprazolam, Trazodone Plasma Control Bi-Level (I + II)</tradeName>
    <deviceName>Alprazolam, Trazodone 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>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0062</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:38:40.715Z</lastUpdated>
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    <udiDi>04250317513595</udiDi>
    <basicUdiDi>B-04250317513595</basicUdiDi>
    <tradeName>Clobazam, Norclobazam Plasma Control Level II</tradeName>
    <deviceName>Clobazam, Norclobazam Plasma Control Level II</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0061/2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:38:37.667Z</lastUpdated>
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    <udiDi>04250317513571</udiDi>
    <basicUdiDi>B-04250317513571</basicUdiDi>
    <tradeName>Clobazam, Norclobazam Plasma Control Level I</tradeName>
    <deviceName>Clobazam, Norclobazam Plasma Control Level I</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0061/1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:38:35.246Z</lastUpdated>
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    <udiDi>04250317513564</udiDi>
    <basicUdiDi>B-04250317513564</basicUdiDi>
    <tradeName>Clobazam, Norclobazam Plasma Control Bi-Level (I + II)</tradeName>
    <deviceName>Clobazam, Norclobazam 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>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0061</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:38:33.668Z</lastUpdated>
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    <udiDi>04250317513137</udiDi>
    <basicUdiDi>B-04250317513137</basicUdiDi>
    <tradeName>Serum Control Level I</tradeName>
    <deviceName>Serum Control Level I</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0060/HR</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:38:32.865Z</lastUpdated>
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