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    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
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    <lastUpdated>2026-07-23T03:54:14.978Z</lastUpdated>
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    <tradeName>GATA-3</tradeName>
    <deviceName>GATA-3</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
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    <deviceName>Galectin-3</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>API3174AA</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
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    <udiDi>00847627003577</udiDi>
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    <tradeName>FOXP3(86D)</tradeName>
    <deviceName>FOXP3(86D)</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACI3197C</reference>
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    <lastUpdated>2026-07-23T03:53:54.914Z</lastUpdated>
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    <udiDi>00847627003454</udiDi>
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    <tradeName>Galectin-3</tradeName>
    <deviceName>Galectin-3</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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    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Galectin-3</tradeName>
    <deviceName>Galectin-3</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
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    <deviceName>FOXP3</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>API3164AA</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:47:46.107Z</lastUpdated>
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    <udiDi>00847627003560</udiDi>
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    <tradeName>FOXP3(86D)</tradeName>
    <deviceName>FOXP3 [86D]</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACI3197A</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:47:42.118Z</lastUpdated>
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    <udiDi>00847627008985</udiDi>
    <basicUdiDi>B-00847627008985</basicUdiDi>
    <tradeName>Folate Receptor alpha IHC Assay Kit</tradeName>
    <deviceName>Folate Receptor alpha IHC Assay Kit</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>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IPI4006KG10</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:42:20.775Z</lastUpdated>
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    <udiDi>00847627005182</udiDi>
    <basicUdiDi>B-00847627005182</basicUdiDi>
    <tradeName>Folate Receptor alpha IHC Assay Kit</tradeName>
    <deviceName>Folate Receptor alpha IHC Assay Kit</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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    <legislation>IVDD</legislation>
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    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BRI4006KAA</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:42:15.156Z</lastUpdated>
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    <udiDi>00615233014559</udiDi>
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    <tradeName>Tissue-Tek Genie® anti-INSM1 Rabbit Monoclonal Antibody [ZR395]</tradeName>
    <deviceName>Tissue-Tek Genie® anti-INSM1 Rabbit Monoclonal Antibody [ZR395]</deviceName>
    <manufacturerName>Sakura Finetek USA, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022208</manufacturerSrn>
    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000007853</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8379-C010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:02:49.102Z</lastUpdated>
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    <udiDi>00615233014481</udiDi>
    <basicUdiDi>06152338306J9</basicUdiDi>
    <tradeName>Tissue-Tek Genie® anti-OCT3/4 Mouse Monoclonal Antibody [C-10]</tradeName>
    <deviceName>Tissue-Tek Genie® anti-OCT3/4 Mouse Monoclonal Antibody [C-10]</deviceName>
    <manufacturerName>Sakura Finetek USA, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022208</manufacturerSrn>
    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000007853</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8288-C010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:02:45.089Z</lastUpdated>
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    <udiDi>00615233013996</udiDi>
    <basicUdiDi>06152338310HY</basicUdiDi>
    <tradeName>Tissue-Tek Genie® anti-TRPS1 Rabbit Polyclonal Antibody [ZR382]</tradeName>
    <deviceName>Tissue-Tek Genie® anti-TRPS1 Rabbit Polyclonal Antibody [ZR382]</deviceName>
    <manufacturerName>Sakura Finetek USA, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022208</manufacturerSrn>
    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000007853</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
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    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8359-M250</reference>
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    <lastUpdated>2026-07-15T22:02:44.286Z</lastUpdated>
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    <udiDi>00615233013965</udiDi>
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    <tradeName>Tissue-Tek Genie®</tradeName>
    <deviceName>Tissue-Tek Genie® anti-Cadherin 17 Rabbit MonoclonalAntibody [QR098]</deviceName>
    <manufacturerName>Sakura Finetek USA, Inc</manufacturerName>
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    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
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    <udiDi>00615233011435</udiDi>
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    <tradeName>Tissue-Tek Genie® anti-SALL4 Mouse Monoclonal Antibody [6E3]</tradeName>
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    <tradeName>Tissue-Tek Genie®</tradeName>
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    <tradeName>Tissue-Tek Genie® anti-MUC2 Mouse Monoclonal Antibody [CCP58]</tradeName>
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