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    <tradeName>Access AFP (300 &amp; 600 Test Kit)</tradeName>
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    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
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    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:35:02.993Z</lastUpdated>
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    <basicUdiDi>150995901AccAFPSamDilDU</basicUdiDi>
    <tradeName>Access AFP Sample Diluent</tradeName>
    <deviceName>Access AFP Sample Diluent</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
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    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <manufacturerName>Biocare Medical</manufacturerName>
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    <manufacturerName>Biocare Medical</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPAI107T60</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:51:47.472Z</lastUpdated>
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    <basicUdiDi>B-00847627024060</basicUdiDi>
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    <deviceName>Bcl-6</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPAI410T60</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:51:46.667Z</lastUpdated>
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    <manufacturerName>Biocare Medical</manufacturerName>
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    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVI410G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:51:45.862Z</lastUpdated>
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    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
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    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PM410AA</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:51:41.862Z</lastUpdated>
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    <manufacturerName>Biocare Medical</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>PM003AA</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:51:41.075Z</lastUpdated>
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    <basicUdiDi>B-00847627008619</basicUdiDi>
    <tradeName>Ber-EP4</tradeName>
    <deviceName>Ber-EP4</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>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP107G10</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:51:40.266Z</lastUpdated>
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    <udiDi>00847627007476</udiDi>
    <basicUdiDi>B-00847627007476</basicUdiDi>
    <tradeName>Bcl-6</tradeName>
    <deviceName>Bcl-6</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>CM410C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:51:39.477Z</lastUpdated>
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    <udiDi>00847627007469</udiDi>
    <basicUdiDi>B-00847627007469</basicUdiDi>
    <tradeName>Bcl-6</tradeName>
    <deviceName>Bcl-6</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>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM410A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:51:35.467Z</lastUpdated>
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    <udiDi>00847627005397</udiDi>
    <basicUdiDi>B-00847627005397</basicUdiDi>
    <tradeName>Bcl-2</tradeName>
    <deviceName>Bcl-2</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>CM003C</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:51:34.659Z</lastUpdated>
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    <udiDi>00847627005380</udiDi>
    <basicUdiDi>B-00847627005380</basicUdiDi>
    <tradeName>Bcl-2</tradeName>
    <deviceName>Bcl-2</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>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM003A</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:51:33.953Z</lastUpdated>
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    <udiDi>00847627034205</udiDi>
    <basicUdiDi>B-00847627034205</basicUdiDi>
    <tradeName>Bcl-2</tradeName>
    <deviceName>Bcl-2</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>OPAI003T60</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-29T20:15:40.606Z</lastUpdated>
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    <udiDi>00847627029324</udiDi>
    <basicUdiDi>B-00847627029324</basicUdiDi>
    <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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    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ALI130G7</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-29T20:15:40.239Z</lastUpdated>
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    <udiDi>00847627024183</udiDi>
    <basicUdiDi>B-00847627024183</basicUdiDi>
    <tradeName>TIA-1</tradeName>
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    <manufacturerName>Biocare Medical</manufacturerName>
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    <reference>AVI130G</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-29T20:15:33.966Z</lastUpdated>
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    <udiDi>00847627012159</udiDi>
    <basicUdiDi>B-00847627012159</basicUdiDi>
    <tradeName>Terminal Deoxynucleotidyl Transferase (TdT {P})</tradeName>
    <deviceName>Terminal Deoxynucleotidyl Transferase (TdT {P})</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>PP134AA</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-29T20:15:33.195Z</lastUpdated>
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    <udiDi>00847627011862</udiDi>
    <basicUdiDi>B-00847627011862</basicUdiDi>
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    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
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    <reference>PM406AA</reference>
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    <lastUpdated>2026-07-29T20:15:29.162Z</lastUpdated>
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    <lastUpdated>2026-07-29T20:15:28.401Z</lastUpdated>
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    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PM022AA</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-29T20:15:27.562Z</lastUpdated>
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