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    <manufacturerName>Biocare Medical</manufacturerName>
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    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <tradeName>Terminal Deoxynucleotidyl Transferase (TdT {P})</tradeName>
    <deviceName>TdT (Polyclonal) 1.0ml</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>00847627007896</udiDi>
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    <tradeName>Terminal Deoxynucleotidyl Transferase (TdT {P})</tradeName>
    <deviceName>TdT (Polyclonal) 0.1ml</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP134AK</reference>
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    <tradeName>B-Catenin</tradeName>
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    <manufacturerName>Biocare Medical</manufacturerName>
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    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <lastUpdated>2026-07-29T20:15:16.365Z</lastUpdated>
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    <tradeName>TIA-1</tradeName>
    <deviceName>TIA-1</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM130B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T20:15:15.559Z</lastUpdated>
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    <tradeName>TIA-1</tradeName>
    <deviceName>TIA-1</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM130A</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-29T20:15:14.763Z</lastUpdated>
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    <udiDi>00847627005588</udiDi>
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    <tradeName>Thyroglobulin</tradeName>
    <deviceName>Thyroglobulin 0.1ml</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM022</reference>
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    <lastUpdated>2026-07-29T20:15:13.969Z</lastUpdated>
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    <tradeName>Total Prostate Specific Antigen (tPSA) Diagnostic Kit (Immunochromatographic Assay)</tradeName>
    <deviceName>Total Prostate Specific Antigen (tPSA) Diagnostic Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-26T03:50:43.119Z</lastUpdated>
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    <deviceName>Free Prostate Specific Antigen (fPSA) Diagnostic Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
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    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Total Prostate Specific Antigen (tPSA) Diagnostic Kit (Immunochromatographic Assay)</tradeName>
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    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
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    <tradeName>Free Prostate Specific Antigen (fPSA) Diagnostic Kit (Immunochromatographic Assay)</tradeName>
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    <manufacturerName>Biocare Medical</manufacturerName>
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