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    <tradeName>09120132230043</tradeName>
    <deviceName>Extraction solution with internal standard for Lyso Triplex</deviceName>
    <manufacturerName>ARCHImedline GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000037501</manufacturerSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <placedOnMarketCountry>Austria</placedOnMarketCountry>
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    <udiDi>84352873309141</udiDi>
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    <deviceName>i-TRA Turbidimetric Calibrator</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
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    <udiDi>84352873309127</udiDi>
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    <deviceName>i-TRA Turbidimetric Calibrator</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
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    <tradeName>Clonatest</tradeName>
    <deviceName>i-FOB Turbidimetric Calibrator</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
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    <udiDi>84352873307222</udiDi>
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    <tradeName>Clonatest</tradeName>
    <deviceName>i-FOB Turbidimetric Calibrator Set</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>CT39000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:33:49.125Z</lastUpdated>
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    <udiDi>84352873307208</udiDi>
    <basicUdiDi>B-84352873307208</basicUdiDi>
    <tradeName>Cromatest</tradeName>
    <deviceName>i-FOB Turbidimetric Calibrator</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>3900005</reference>
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    <lastUpdated>2026-07-17T01:33:43.136Z</lastUpdated>
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    <udiDi>D-70305GL</udiDi>
    <basicUdiDi>B-70305GL</basicUdiDi>
    <tradeName>Standard Solution Set</tradeName>
    <deviceName>Standard Solution Set</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <tradeName>NEFA Standard</tradeName>
    <deviceName>NEFA-HR(2) R1 Set, NEFA-HR(2) R2 Set, NEFA Standard</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
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    <reference>991-91791</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <tradeName>MassTrak™</tradeName>
    <deviceName>MassTrak™ Endocrine Product Family</deviceName>
    <manufacturerName>Waters Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000025801</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <reference>186010560IVD</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:22:13.937Z</lastUpdated>
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    <udiDi>00811403019038</udiDi>
    <basicUdiDi>081140301SMB03417601D2G</basicUdiDi>
    <tradeName>Standard solution</tradeName>
    <deviceName>ISE High/Low Urine Standard ADVIA</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034351</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM-B03417601D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:10:32.141Z</lastUpdated>
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    <udiDi>00811403019021</udiDi>
    <basicUdiDi>081140301SMB03417501D29</basicUdiDi>
    <tradeName>Standard solution</tradeName>
    <deviceName>ISE High/Low Serum Standard ADVIA</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM-B03417501D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:10:30.531Z</lastUpdated>
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    <udiDi>00811403018949</udiDi>
    <basicUdiDi>081140301SMB01417351DZB</basicUdiDi>
    <tradeName>Reference solution</tradeName>
    <deviceName>ISE Reference Solution ADVIA</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
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    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM-B01417351D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:10:17.741Z</lastUpdated>
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    <basicUdiDi>081140301SMB01417151DYV</basicUdiDi>
    <tradeName>Buffer solution</tradeName>
    <deviceName>ISE Buffer ADVIA</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-16T01:10:15.323Z</lastUpdated>
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    <tradeName>Fluid pack</tradeName>
    <deviceName>Fluid Pack Na-K-Cl Spotlyte</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>MN-2121D</reference>
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    <lastUpdated>2026-07-16T01:10:13.721Z</lastUpdated>
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    <tradeName>Standard solution</tradeName>
    <deviceName>ISE Internal Standard C501</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
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    <reference>RO-4522320D</reference>
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    <lastUpdated>2026-07-16T01:10:11.320Z</lastUpdated>
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    <basicUdiDi>081140301RD943839DQM</basicUdiDi>
    <tradeName>Calibrator solution</tradeName>
    <deviceName>Calibrator 2 Solution RD5</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
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    <tradeName>Calibrator solution</tradeName>
    <deviceName>Calibrator 1 Solution RD5</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
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    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
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    <lastUpdated>2026-07-16T01:09:44.038Z</lastUpdated>
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    <tradeName>Buffer solution</tradeName>
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    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
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    <tradeName>Buffer solution</tradeName>
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    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
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    <tradeName>Calibration solution</tradeName>
    <deviceName>THB Calibration Solution</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
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    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-16T01:09:32.830Z</lastUpdated>
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