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    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
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    <tradeName>Boditech PSA Calibrator</tradeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Greece</placedOnMarketCountry>
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    <tradeName>Inhibin B Gen II Calibrators and Controls</tradeName>
    <deviceName>Inhibin B Gen II Calibrators and Controls</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
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    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A81304</reference>
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    <lastUpdated>2026-07-01T08:52:42.397Z</lastUpdated>
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    <tradeName>Access OV Monitor (Calibrators)</tradeName>
    <deviceName>Access OV Monitor (Calibrators)</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>
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    <deviceName>Access Hybritech free PSA (Calibrators)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
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    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Access GI Monitor (Calibrators)</tradeName>
    <deviceName>Access GI Monitor (Calibrators)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>387688</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:37:30.826Z</lastUpdated>
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    <basicUdiDi>150995901AccAFPCalZH</basicUdiDi>
    <tradeName>Access AFP (Calibrators)</tradeName>
    <deviceName>Access AFP (Calibrators)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <emdnCode>W0102152205</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33215</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:37:20.422Z</lastUpdated>
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    <udiDi>15099590224585</udiDi>
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    <tradeName>Access Hybritech PSA (Calibrator)</tradeName>
    <deviceName>Access Hybritech PSA (Calibrator)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
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    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:36:08.321Z</lastUpdated>
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    <tradeName>Access Hybritech p2PSA (Calibrators)</tradeName>
    <deviceName>Access Hybritech p2PSA (Calibrators)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-01T08:35:24.242Z</lastUpdated>
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    <tradeName>Boditech iFOB Neo Calibrator</tradeName>
    <deviceName>Boditech iFOB Neo Calibrator</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFPO-379</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T02:38:39.406Z</lastUpdated>
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    <tradeName>AutoLumo PIVKA-II CLIA Calibrators</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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    <lastUpdated>2026-06-30T09:16:57.374Z</lastUpdated>
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    <tradeName>AutoLumo CA19-9 Calibrators</tradeName>
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    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
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    <tradeName>AutoLumo SCCA Calibrators</tradeName>
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    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
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    <tradeName>AutoLumo ProGRP Calibrators</tradeName>
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    <tradeName>AutoLumo HE4 Calibrators</tradeName>
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