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    <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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    <deviceStatus>Piyasada</deviceStatus>
    <reference>OY-AUH1018BD</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:08:44.727Z</lastUpdated>
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    <tradeName>Selectivity check</tradeName>
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    <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>OY-AUH1018AD</reference>
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    <tradeName>Reference solution</tradeName>
    <deviceName>ISE Internal Reference Solution, AU</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
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    <reference>OY-AUH1017D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
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    <tradeName>Selectivity check</tradeName>
    <deviceName>Na/K Selectivity Check Solution</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>
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    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OY-AUH1018D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:08:36.827Z</lastUpdated>
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    <udiDi>00811403016570</udiDi>
    <basicUdiDi>081140301OYAUH1016D7E</basicUdiDi>
    <tradeName>Standard solution</tradeName>
    <deviceName>Low/High Urine Standard</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>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OY-AUH1016D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:08:36.680Z</lastUpdated>
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    <udiDi>00811403016563</udiDi>
    <basicUdiDi>081140301OYAUH1016BDRT</basicUdiDi>
    <tradeName>Standard solution</tradeName>
    <deviceName>Standard High Urine</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>
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    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:08:32.032Z</lastUpdated>
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    <tradeName>Standard solution</tradeName>
    <deviceName>Standard Low Urine</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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    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:08:31.121Z</lastUpdated>
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    <tradeName>Standard solution</tradeName>
    <deviceName>ISE High Standard</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OY-AUH1015D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:08:30.765Z</lastUpdated>
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    <udiDi>00811403016532</udiDi>
    <basicUdiDi>081140301OYAUH1014D78</basicUdiDi>
    <tradeName>Standard solution</tradeName>
    <deviceName>ISE Low Standard</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>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OY-AUH1014D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:08:29.535Z</lastUpdated>
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    <udiDi>00811403016525</udiDi>
    <basicUdiDi>081140301OYAUH1013D75</basicUdiDi>
    <tradeName>Reference solution</tradeName>
    <deviceName>ISE Reference Solution</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>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OY-AUH1013D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:08:25.557Z</lastUpdated>
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    <udiDi>00811403016518</udiDi>
    <basicUdiDi>081140301OYAUH1012D72</basicUdiDi>
    <tradeName>Standard solution</tradeName>
    <deviceName>ISE Mid-Standard</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>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OY-AUH1012D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:08:24.798Z</lastUpdated>
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    <udiDi>00811403016501</udiDi>
    <basicUdiDi>081140301OYAUH1011D6X</basicUdiDi>
    <tradeName>Buffer solution</tradeName>
    <deviceName>ISE Buffer</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>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OY-AUH1011D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:08:24.460Z</lastUpdated>
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    <udiDi>00811403016006</udiDi>
    <basicUdiDi>081140301ME2577DFE</basicUdiDi>
    <tradeName>Standard solution</tradeName>
    <deviceName>Urine Standard</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>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-2577D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:08:19.105Z</lastUpdated>
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    <udiDi>00811403015917</udiDi>
    <basicUdiDi>081140301ME2123DDD</basicUdiDi>
    <tradeName>Fluid pack</tradeName>
    <deviceName>Fluid Pack Eastlyte Na-K-Ca-pH</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>
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    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-2123D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:08:06.298Z</lastUpdated>
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    <udiDi>00811403015900</udiDi>
    <basicUdiDi>081140301ME6370DFP</basicUdiDi>
    <tradeName>Standard solution</tradeName>
    <deviceName>Standard A ISE Module</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>ME-6370D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:08:04.701Z</lastUpdated>
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    <udiDi>00811403015894</udiDi>
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    <tradeName>Fluid pack</tradeName>
    <deviceName>Fluid Pack Easylyte Na-K-Cl</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>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-2121D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:08:03.908Z</lastUpdated>
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    <basicUdiDi>081140301ME5410DEM</basicUdiDi>
    <tradeName>Standard solution</tradeName>
    <deviceName>Standard B ISE Module</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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    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-5410D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:07:58.943Z</lastUpdated>
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    <tradeName>Fluid pack</tradeName>
    <deviceName>Fluid Pack Ilyte NA/K/Ca/pH</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
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    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IL-2123D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:07:12.997Z</lastUpdated>
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    <tradeName>Fluid pack</tradeName>
    <deviceName>Fluid Pack</deviceName>
    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
    <manufacturerSrn>US-MF-000035435</manufacturerSrn>
    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
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    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:07:12.202Z</lastUpdated>
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    <manufacturerName>Diamond Diagnostics Inc</manufacturerName>
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    <authorisedRepresentativeName>Diamond Diagnostics Inc. Magyarországi Fióktelepe</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:07:11.417Z</lastUpdated>
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