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    <tradeName>ONE‐CAL 2</tradeName>
    <deviceName>ONE‐CAL 2</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <udiDi>D-CN383000Y5</udiDi>
    <basicUdiDi>B-CN383000Y5</basicUdiDi>
    <tradeName>D-CN383000Y5</tradeName>
    <deviceName>UF-Calibrator</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
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    <udiDi>42625753901464</udiDi>
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    <tradeName>Z-Hb Confirm HbA1c Calibrator kit</tradeName>
    <deviceName>Z-Hb Confirm HbA1c Calibrator Kit</deviceName>
    <manufacturerName>ZOVEC diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035393</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z-RHBCA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:42:50.479Z</lastUpdated>
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    <udiDi>D-100187776A</udiDi>
    <basicUdiDi>B-100187776A</basicUdiDi>
    <tradeName>Cascadion™ SM Immunosuppressants Panel Internal Standard</tradeName>
    <deviceName>Cascadion™ SM Immunosuppressants Panel Internal Standard</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10018777</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:36:00.623Z</lastUpdated>
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    <udiDi>D-100187725Y</udiDi>
    <basicUdiDi>B-100187725Y</basicUdiDi>
    <tradeName>Cascadion™ SM Immunosuppressants Panel Calibrator Set</tradeName>
    <deviceName>Cascadion™ SM Immunosuppressants Panel Calibrator Set</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10018772</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:35:55.823Z</lastUpdated>
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    <udiDi>D-100187645Z</udiDi>
    <basicUdiDi>B-100187645Z</basicUdiDi>
    <tradeName>Cascadion™ SM 25-Hydroxy Vitamin D Internal Standard</tradeName>
    <deviceName>Cascadion™ SM 25-Hydroxy Vitamin D Internal Standard</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</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>Artık piyasada değil</deviceStatus>
    <reference>10018764</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:35:55.045Z</lastUpdated>
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    <udiDi>D-100187605R</udiDi>
    <basicUdiDi>B-100187605R</basicUdiDi>
    <tradeName>Cascadion™ SM 25-Hydroxy Vitamin D Calibrator Set</tradeName>
    <deviceName>Cascadion™ SM 25-Hydroxy Vitamin D Calibrator Set</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10018760</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:35:33.376Z</lastUpdated>
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    <udiDi>08057441870077</udiDi>
    <basicUdiDi>B-08057441870077</basicUdiDi>
    <tradeName>KIT ANTIBIOTICI OPTIMIZATION MIX SET B</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CoQua Lab s.r.l</manufacturerName>
    <manufacturerSrn>IT-MF-000053829</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>ATB100B_OPT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:33:09.283Z</lastUpdated>
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    <udiDi>08057441870039</udiDi>
    <basicUdiDi>B-08057441870039</basicUdiDi>
    <tradeName>KIT ANTIBIOTICI OPTIMIZATION MIX SET A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CoQua Lab s.r.l</manufacturerName>
    <manufacturerSrn>IT-MF-000053829</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATB100A_OPT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:33:02.888Z</lastUpdated>
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    <udiDi>06978467910221</udiDi>
    <basicUdiDi>B-06978467910221</basicUdiDi>
    <tradeName>AllDx</tradeName>
    <deviceName>Cholesterol Control solution</deviceName>
    <manufacturerName>Hangzhou Aokai Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048311</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS108-0011</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:44:17.475Z</lastUpdated>
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    <udiDi>06978467910207</udiDi>
    <basicUdiDi>B-06978467910207</basicUdiDi>
    <tradeName>AllDx</tradeName>
    <deviceName>Uric Acid Control solution</deviceName>
    <manufacturerName>Hangzhou Aokai Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048311</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS104-0011</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:44:13.468Z</lastUpdated>
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    <udiDi>06978467910191</udiDi>
    <basicUdiDi>B-06978467910191</basicUdiDi>
    <tradeName>AllDx</tradeName>
    <deviceName>Blood Ketone Control solution</deviceName>
    <manufacturerName>Hangzhou Aokai Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048311</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS103-0011</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:44:12.676Z</lastUpdated>
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    <udiDi>03661540301506</udiDi>
    <basicUdiDi>B-03661540301506</basicUdiDi>
    <tradeName>03661540301506</tradeName>
    <deviceName>Optimole Osmolality Standard 1000 mmol/kg</deviceName>
    <manufacturerName>ELITechGroup Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006942</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OA-100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:16:52.268Z</lastUpdated>
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    <udiDi>03661540301490</udiDi>
    <basicUdiDi>B-03661540301490</basicUdiDi>
    <tradeName>03661540301490</tradeName>
    <deviceName>Optimole Osmolality Standard 290 mmol/kg</deviceName>
    <manufacturerName>ELITechGroup Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006942</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:16:51.475Z</lastUpdated>
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    <udiDi>03661540301483</udiDi>
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    <tradeName>03661540301483</tradeName>
    <deviceName>Optimole Osmolality Standard 100 mmol/kg</deviceName>
    <manufacturerName>ELITechGroup Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000006942</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T14:16:47.460Z</lastUpdated>
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    <udiDi>08430793041126</udiDi>
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    <tradeName>Aptiva® Optical Calibrator Kit</tradeName>
    <deviceName>Aptiva® Optical Calibrator Kit</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <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>AC1001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:26:10.163Z</lastUpdated>
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    <udiDi>06972873820198</udiDi>
    <basicUdiDi>697287382TS74</basicUdiDi>
    <tradeName>Calibration Standard Solution</tradeName>
    <deviceName>Calibration Standard Solution</deviceName>
    <manufacturerName>Shenzhen Cornley Bio-Medical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017322</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
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    <reference>/</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:18:57.100Z</lastUpdated>
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    <tradeName>Ketone Body Calibrator 300</tradeName>
    <deviceName>Ketone Body Calibrator 300</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
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    <reference>993-73791</reference>
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    <lastUpdated>2026-07-01T22:07:06.536Z</lastUpdated>
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    <udiDi>04050598011991</udiDi>
    <basicUdiDi>4050598LCACVITQV</basicUdiDi>
    <tradeName>Tuning solution for the analyte</tradeName>
    <deviceName>Accessories for 1,25-(OH)2-Vitamin D3/D2 LC-MS/MS product variants</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM1000TU</reference>
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    <lastUpdated>2026-07-01T16:16:19.511Z</lastUpdated>
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    <tradeName>Tuning solution for the analyte</tradeName>
    <deviceName>Accessories for Hepcidin-25 LC-MS/MS</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM4000TU</reference>
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    <lastUpdated>2026-07-01T16:16:17.919Z</lastUpdated>
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