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    <tradeName>Internal Standard Mix</tradeName>
    <deviceName>Internal Standard Mix</deviceName>
    <manufacturerName>Chromsystems Instruments + Chemicals GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:42:17.578Z</lastUpdated>
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    <udiDi>04250317523969</udiDi>
    <basicUdiDi>B-04250317523969</basicUdiDi>
    <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>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92031</reference>
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    <lastUpdated>2026-09-22T08:42:16.849Z</lastUpdated>
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    <udiDi>04250317523891</udiDi>
    <basicUdiDi>B-04250317523891</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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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:42:16.286Z</lastUpdated>
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    <udiDi>04250317523884</udiDi>
    <basicUdiDi>B-04250317523884</basicUdiDi>
    <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>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92030</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:42:16.163Z</lastUpdated>
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    <udiDi>04250317523822</udiDi>
    <basicUdiDi>B-04250317523822</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>38910</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:42:11.232Z</lastUpdated>
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    <udiDi>04250317523785</udiDi>
    <basicUdiDi>B-04250317523785</basicUdiDi>
    <tradeName>HPLC Reagent Kit 25-OH-Vitamin D3/D2 in Serum/Plasma (Online Method)</tradeName>
    <deviceName>25-OH-Vitamin D3/D2 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>38900/1000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:42:10.586Z</lastUpdated>
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    <udiDi>04250317523761</udiDi>
    <basicUdiDi>B-04250317523761</basicUdiDi>
    <tradeName>Trap column</tradeName>
    <deviceName>Trap 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>38920</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:42:10.033Z</lastUpdated>
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    <udiDi>04250317523754</udiDi>
    <basicUdiDi>B-04250317523754</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>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>38904</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:42:08.949Z</lastUpdated>
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    <udiDi>04250317523747</udiDi>
    <basicUdiDi>B-04250317523747</basicUdiDi>
    <tradeName>Mobile Phase B</tradeName>
    <deviceName>Mobile Phase B</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>38902</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:42:04.936Z</lastUpdated>
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    <udiDi>04250317523730</udiDi>
    <basicUdiDi>B-04250317523730</basicUdiDi>
    <tradeName>Mobile Phase A</tradeName>
    <deviceName>Mobile Phase A</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>38901</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:42:04.378Z</lastUpdated>
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    <udiDi>04250317520364</udiDi>
    <basicUdiDi>B-04250317520364</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>37110</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:42:03.690Z</lastUpdated>
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    <udiDi>04250317520357</udiDi>
    <basicUdiDi>B-04250317520357</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>37022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:42:03.600Z</lastUpdated>
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    <udiDi>04250317520326</udiDi>
    <basicUdiDi>B-04250317520326</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>37011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:41:59.489Z</lastUpdated>
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    <udiDi>04250317520074</udiDi>
    <basicUdiDi>B-04250317520074</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>
    <legislation>IVDD</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18068</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:41:59.409Z</lastUpdated>
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    <udiDi>04250317520043</udiDi>
    <basicUdiDi>B-04250317520043</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>
    <legislation>IVDD</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18065</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:41:56.222Z</lastUpdated>
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    <udiDi>04250317519863</udiDi>
    <basicUdiDi>B-04250317519863</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>
    <legislation>IVDD</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18032</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:41:55.957Z</lastUpdated>
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    <udiDi>04250317519061</udiDi>
    <basicUdiDi>B-04250317519061</basicUdiDi>
    <tradeName>HPLC Reagent Kit CDT FE in serum for ternary gradient systems Fast Elution</tradeName>
    <deviceName>CDT FE in serum</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>54330/500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:41:51.083Z</lastUpdated>
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    <udiDi>04250317519054</udiDi>
    <basicUdiDi>B-04250317519054</basicUdiDi>
    <tradeName>Mobile Phase C</tradeName>
    <deviceName>Mobile Phase C</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>54333</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:41:50.306Z</lastUpdated>
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    <udiDi>04250317519047</udiDi>
    <basicUdiDi>B-04250317519047</basicUdiDi>
    <tradeName>Mobile Phase B</tradeName>
    <deviceName>Mobile Phase B</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>54332</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:41:49.503Z</lastUpdated>
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    <udiDi>04250317519030</udiDi>
    <basicUdiDi>B-04250317519030</basicUdiDi>
    <tradeName>Mobile Phase A</tradeName>
    <deviceName>Mobile Phase A</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>54331</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-22T08:41:48.683Z</lastUpdated>
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