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    <tradeName>Borg Decloaker, RTU</tradeName>
    <deviceName>Antigen Retrieval Reagent for IHC</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
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    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <reference>BD1000G1</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:57.586Z</lastUpdated>
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    <tradeName>Aqua DePar, 10X</tradeName>
    <deviceName>Aqua Depar, 10X</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
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    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <basicUdiDi>08476270BPERBLKRZ9</basicUdiDi>
    <tradeName>intelliPATH FLX™ Peroxidase Blocking Reagent</tradeName>
    <deviceName>Peroxidazed 1</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
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    <reference>IPB5000G20</reference>
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    <tradeName>MACH 4 MR Universal AP Detection System</tradeName>
    <deviceName>MACH Mirco-Polymer Detection System for IHC</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BRI4005L</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:35.910Z</lastUpdated>
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    <basicUdiDi>08476270BBP974B7</basicUdiDi>
    <tradeName>Background Punisher</tradeName>
    <deviceName>Protein Blocking Reagents for IHC</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BP974H</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:35.099Z</lastUpdated>
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    <udiDi>00847627005076</udiDi>
    <basicUdiDi>08476270BBDB200486</basicUdiDi>
    <tradeName>Betazoid DAB Chromogen Kit</tradeName>
    <deviceName>Betazoid DAB Chromogen Kits for IHC</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BDB2004H</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:34.303Z</lastUpdated>
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    <basicUdiDi>08476270BLSABKE</basicUdiDi>
    <tradeName>4plus Universal AP Detection</tradeName>
    <deviceName>LSAB (Streptavidin) Detection Systems for IHC</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>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AP506US</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:29.530Z</lastUpdated>
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    <tradeName>Betazoid DAB Chromogen Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>BDB2004L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T15:08:18.196Z</lastUpdated>
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    <tradeName>Betazoid DAB Chromogen Kit</tradeName>
    <deviceName></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>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BDB2004MM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T15:08:18.169Z</lastUpdated>
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    <tradeName>Background Punisher</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W01029099</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>BP974L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T15:08:18.123Z</lastUpdated>
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    <tradeName>Background Punisher</tradeName>
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    <manufacturerName>Biocare Medical</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>BP974M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <tradeName>MACH 4 Universal HRP-Polymer Detection System</tradeName>
    <deviceName></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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    <tradeName>MACH 4 Universal HRP-Polymer Detection System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>BRI4012H</reference>
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    <tradeName>MACH 4 Universal HRP-Polymer Detection System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
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    <tradeName>4plus Biotinylated Goat Anti-Mouse IgG</tradeName>
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    <deviceStatus>Piyasada</deviceStatus>
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