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    <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>
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    <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>
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    <udiDi>04260157630741</udiDi>
    <basicUdiDi>426015763810BTPSAKCALXXQB</basicUdiDi>
    <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>
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    <reference>081091N</reference>
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    <lastUpdated>2026-07-30T22:32:57.571Z</lastUpdated>
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    <udiDi>08431673170615</udiDi>
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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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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>1107082</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:22:07.519Z</lastUpdated>
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    <udiDi>08431673170325</udiDi>
    <basicUdiDi>B-08431673170325</basicUdiDi>
    <tradeName>ß2-m-CAL</tradeName>
    <deviceName>ß2-microglobulin Calibrator</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152205</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1107032</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:21:37.034Z</lastUpdated>
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    <udiDi>00630414622804</udiDi>
    <basicUdiDi>0405686902360VJ</basicUdiDi>
    <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>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</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>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>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_CAL Y</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995520</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:48:53.937Z</lastUpdated>
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    <udiDi>00630414599182</udiDi>
    <basicUdiDi>0405686901854W9</basicUdiDi>
    <tradeName>Atellica IM Her-2/neu Quality Control (H2n QC)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_H2n QC</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
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    <emdnCode>W0102152205</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995594</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:40:16.195Z</lastUpdated>
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    <udiDi>00630414599168</udiDi>
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    <tradeName>Atellica IM HER-2/neu Calibrator (H2n CAL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_H2n Cal</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</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>10995592</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:40:15.395Z</lastUpdated>
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    <udiDi>00630414598420</udiDi>
    <basicUdiDi>0405686901826W4</basicUdiDi>
    <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>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995515</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:40:02.608Z</lastUpdated>
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    <udiDi>00630414611693</udiDi>
    <basicUdiDi>0405686902360VJ</basicUdiDi>
    <tradeName>ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (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>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</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>11553956</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:36:36.745Z</lastUpdated>
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    <udiDi>00630414608273</udiDi>
    <basicUdiDi>0405686902362VN</basicUdiDi>
    <tradeName>ADVIA Centaur Tumor Marker Quality Control (TM QC)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_TM QC</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</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>11538186</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:36:08.212Z</lastUpdated>
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    <udiDi>00630414598376</udiDi>
    <basicUdiDi>0405686901831VV</basicUdiDi>
    <tradeName>Atellica IM Calibrator D (CAL D)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_CAL D</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995510</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:35:54.252Z</lastUpdated>
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    <udiDi>00630414598147</udiDi>
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    <tradeName>Atellica IM CA 15-3 Calibrator (CA15-3 CAL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_CA 15-3 Calibrator</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</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>10995487</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:35:50.243Z</lastUpdated>
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    <basicUdiDi>0405686901828W8</basicUdiDi>
    <tradeName>Atellica IM CA 125II Calibrator (CA 125II CAL)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_CA 125II Cal</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995483</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:35:49.450Z</lastUpdated>
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    <udiDi>00630414557748</udiDi>
    <basicUdiDi>0405686901852W5</basicUdiDi>
    <tradeName>ADVIA Centaur  Free PSA Calibrator (fPSA Cal)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_Free PSA Calibrator</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
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    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10361919</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:34:26.398Z</lastUpdated>
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    <tradeName>N FLC Standard SL</tradeName>
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    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
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    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10482440</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:07:46.020Z</lastUpdated>
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    <tradeName>APO CAL Apolipoprotein Calibrator</tradeName>
    <deviceName>APO CAL Apolipoprotein Calibrator</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
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    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>469283</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:54:25.111Z</lastUpdated>
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    <tradeName>Atellica IM Tumor Marker Quality Control (TM QC)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
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    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11538187</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:44:59.870Z</lastUpdated>
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    <tradeName>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>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
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    <emdnCode>W0102152205</emdnCode>
    <emdnDescription>HER-2/NEU</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMB2210</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:47:21.300Z</lastUpdated>
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