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    <deviceName>FastPack Total PSA Calibrator 25s Kit</deviceName>
    <manufacturerName>Qualigen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000025168</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
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    <lastUpdated>2026-09-21T20:00:55.826Z</lastUpdated>
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    <tradeName>Atellica IM NSE Calibrator (NSE CAL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_NSE CAL</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
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    <lastUpdated>2026-08-05T12:38:40.351Z</lastUpdated>
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    <tradeName>ADVIA Centaur NSE Calibrator (NSE CAL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_NSE CAL</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
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    <lastUpdated>2026-08-04T17:55:41.414Z</lastUpdated>
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    <udiDi>05415168004749</udiDi>
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    <tradeName>Beta2-microglobulin urine calibrator kit</tradeName>
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    <manufacturerName>Diagam S.A.</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0102152205</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>BUREK-000</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:26:33.098Z</lastUpdated>
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    <udiDi>05415168004015</udiDi>
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    <tradeName>Beta2-microglobulin calibrator kit</tradeName>
    <deviceName>Beta2-microglobulin calibrator kit</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B2REK-000</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T18:26:06.709Z</lastUpdated>
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    <udiDi>06942359521680</udiDi>
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    <tradeName>AutoLumo S100 Calibrators</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152205</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA062301</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:48:23.975Z</lastUpdated>
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    <tradeName>AutoLumo HER-2/neu CLIA Microparticles</tradeName>
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    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152205</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA062201</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:48:23.184Z</lastUpdated>
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    <tradeName>μTASWako DCP Calibrator Set</tradeName>
    <deviceName>μTASWako DCP, μTASWako DCP Calibrator Set, μTASWako DCP Control L, μTASWako DCP Control H</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152205</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>999-61201</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:41:18.861Z</lastUpdated>
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    <tradeName>μTASWako AFP-L3 Calibrator Set</tradeName>
    <deviceName>μTASWako AFP-L3, μTASWako AFP-L3 Calibrator Set, μTASWako AFP-L3 Control L, μTASWako AFP-L3 Control H</deviceName>
    <manufacturerName>FUJIFILM Wako Pure Chemical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000013944</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Wako Chemicals Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011552</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152205</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>997-60901</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:41:14.861Z</lastUpdated>
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    <udiDi>04987274108709</udiDi>
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    <tradeName>FIT Hemoglobin NS-Prime Calibrator</tradeName>
    <deviceName>FIT Hemoglobin NS-Prime Calibrator</deviceName>
    <manufacturerName>Alfresa Pharma Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000008778</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152205</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>910870</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:31:54.746Z</lastUpdated>
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    <udiDi>04260157632332</udiDi>
    <basicUdiDi>426015763867BFrPSAKQCXXPM</basicUdiDi>
    <tradeName>B·R·A·H·M·S Free PSA KRYPTOR QC</tradeName>
    <deviceName>B·R·A·H·M·S Free PSA KRYPTOR QC</deviceName>
    <manufacturerName>B·R·A·H·M·S GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026030</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152205</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>086792N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:37:53.680Z</lastUpdated>
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    <udiDi>04260157632325</udiDi>
    <basicUdiDi>426015763867BFPSAKCALXXS5</basicUdiDi>
    <tradeName>B·R·A·H·M·S Free PSA KRYPTOR CAL</tradeName>
    <deviceName>B·R·A·H·M·S Free PSA KRYPTOR CAL</deviceName>
    <manufacturerName>B·R·A·H·M·S GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026030</manufacturerSrn>
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    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>086791N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:37:49.661Z</lastUpdated>
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    <tradeName>B·R·A·H·M·S Total PSA KRYPTOR CAL</tradeName>
    <deviceName>B·R·A·H·M·S Total PSA KRYPTOR CAL</deviceName>
    <manufacturerName>B·R·A·H·M·S GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000026030</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>081091N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:32:57.571Z</lastUpdated>
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    <tradeName>FOB-CAL</tradeName>
    <deviceName>Fecal ocult blood calibrator</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>1107082</reference>
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    <lastUpdated>2026-07-23T21:22:07.519Z</lastUpdated>
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    <tradeName>ß2-m-CAL</tradeName>
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    <lastUpdated>2026-07-23T21:21:37.034Z</lastUpdated>
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    <tradeName>Atellica IM Cytokeratin Fragment Calibrator 21-1 (CYFRA CAL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_CYFRA CAL</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>11553957</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T06:08:59.699Z</lastUpdated>
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    <tradeName>Atellica IM Calibrator Y (CAL Y)</tradeName>
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    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
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    <lastUpdated>2026-07-20T19:48:53.937Z</lastUpdated>
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    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
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    <lastUpdated>2026-07-17T19:40:16.195Z</lastUpdated>
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    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
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    <lastUpdated>2026-07-17T19:40:15.395Z</lastUpdated>
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    <tradeName>Atellica IM BR 27.29 Calibrator (BR CAL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_BR CAL</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
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    <reference>10995515</reference>
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    <lastUpdated>2026-07-17T19:40:02.608Z</lastUpdated>
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