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    <tradeName>Wash Buffer</tradeName>
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    <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>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-09-22T08:33:38.655Z</lastUpdated>
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    <basicUdiDi>B-04250317503848</basicUdiDi>
    <tradeName>Equilibration Buffer</tradeName>
    <deviceName>Equilibration Buffer</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
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    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <basicUdiDi>B-04250317503800</basicUdiDi>
    <tradeName>Internal Standard</tradeName>
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    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <tradeName>Internal Standard</tradeName>
    <deviceName>Internal Standard</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>23004/A5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:33:18.275Z</lastUpdated>
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    <udiDi>04250317503787</udiDi>
    <basicUdiDi>B-04250317503787</basicUdiDi>
    <tradeName>Internal Standard</tradeName>
    <deviceName>Internal Standard</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>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:33:15.838Z</lastUpdated>
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    <udiDi>04250317503732</udiDi>
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    <tradeName>HPLC Reagent Kit Antiepileptic Drugs in serum/plasma, HIGH RESOLUTION</tradeName>
    <deviceName>Antiepileptic Drugs in serum/plasma</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>23000/HR</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:33:15.772Z</lastUpdated>
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    <udiDi>04250317503718</udiDi>
    <basicUdiDi>B-04250317503718</basicUdiDi>
    <tradeName>HPLC Reagent Kit Antiepileptic Drugs in serum/plasma, FAST ELUTION</tradeName>
    <deviceName>Antiepileptic Drugs in serum/plasma</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>23000/F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:33:09.295Z</lastUpdated>
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    <udiDi>04250317503657</udiDi>
    <basicUdiDi>B-04250317503657</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>22100/HR</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:33:08.065Z</lastUpdated>
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    <udiDi>04250317503572</udiDi>
    <basicUdiDi>B-04250317503572</basicUdiDi>
    <tradeName>Serum Calibration Standard</tradeName>
    <deviceName>Serum 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>22005/HR</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:33:03.188Z</lastUpdated>
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    <udiDi>04250317503558</udiDi>
    <basicUdiDi>B-04250317503558</basicUdiDi>
    <tradeName>Serum Calibration Standard</tradeName>
    <deviceName>Serum 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>22005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:33:02.329Z</lastUpdated>
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    <udiDi>04250317503466</udiDi>
    <basicUdiDi>B-04250317503466</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>22001/HR</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:32:56.750Z</lastUpdated>
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    <udiDi>04250317503442</udiDi>
    <basicUdiDi>B-04250317503442</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>22001/F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:32:56.253Z</lastUpdated>
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    <udiDi>04250317503367</udiDi>
    <basicUdiDi>B-04250317503367</basicUdiDi>
    <tradeName>HPLC Reagent Kit Antiepileptic Drugs in Serum/Plasma – FAST ELUTION</tradeName>
    <deviceName>Antiepileptic Drugs in Serum/Plasma</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>22000/F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:32:55.498Z</lastUpdated>
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    <udiDi>04250317503398</udiDi>
    <basicUdiDi>B-04250317503398</basicUdiDi>
    <tradeName>HPLC Reagent Kit Antiepileptic Drugs in Serum/Plasma – 
HIGH RESOLUTION</tradeName>
    <deviceName>Antiepileptic Drugs in Serum/Plasma</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22000/HR</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:32:53.484Z</lastUpdated>
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    <udiDi>04250317502780</udiDi>
    <basicUdiDi>B-04250317502780</basicUdiDi>
    <tradeName>Serum Control, Level III</tradeName>
    <deviceName>Serum Control, Level III</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>0180</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:32:42.833Z</lastUpdated>
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    <udiDi>04250317502537</udiDi>
    <basicUdiDi>B-04250317502537</basicUdiDi>
    <tradeName>Precolumn cartridge 4/10</tradeName>
    <deviceName>Precolumn cartridge 4/10</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:32:42.203Z</lastUpdated>
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    <udiDi>04250317502452</udiDi>
    <basicUdiDi>B-04250317502452</basicUdiDi>
    <tradeName>Precolumn cartridge</tradeName>
    <deviceName>Precolumn cartridge</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17037</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:32:41.660Z</lastUpdated>
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    <udiDi>04250317502209</udiDi>
    <basicUdiDi>B-04250317502209</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>
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    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:32:34.432Z</lastUpdated>
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    <udiDi>04250317502223</udiDi>
    <basicUdiDi>B-04250317502223</basicUdiDi>
    <tradeName>Serum Control Level II</tradeName>
    <deviceName>Serum 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>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:32:25.783Z</lastUpdated>
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    <udiDi>04250317502247</udiDi>
    <basicUdiDi>B-04250317502247</basicUdiDi>
    <tradeName>Serum Control, Level II</tradeName>
    <deviceName>Serum 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>0170</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:32:24.979Z</lastUpdated>
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