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    <tradeName>Uroplakin III</tradeName>
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    <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>
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    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACI3023A</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:23:50.378Z</lastUpdated>
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    <basicUdiDi>B-00847627013804</basicUdiDi>
    <tradeName>Melanoma Cocktail</tradeName>
    <deviceName>Melanoma Cocktail</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VP078G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:56:47.229Z</lastUpdated>
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    <udiDi>00847627005984</udiDi>
    <basicUdiDi>B-00847627005984</basicUdiDi>
    <tradeName>Melanoma Cocktail</tradeName>
    <deviceName>Melanoma Cocktail</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>CM078B</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:56:42.405Z</lastUpdated>
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    <tradeName>Mesothelin</tradeName>
    <deviceName>ACI3175B</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>ACI3175B</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:56:41.652Z</lastUpdated>
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    <udiDi>00847627010896</udiDi>
    <basicUdiDi>B-00847627010896</basicUdiDi>
    <tradeName>Melanoma Cocktail</tradeName>
    <deviceName>Melanoma Cocktail</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>PM078AA</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:56:40.803Z</lastUpdated>
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    <udiDi>00847627005991</udiDi>
    <basicUdiDi>B-00847627005991</basicUdiDi>
    <tradeName>Melanoma Cocktail</tradeName>
    <deviceName>Melanoma Cocktail</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>CM078C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:56:40.007Z</lastUpdated>
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    <udiDi>00847627003461</udiDi>
    <basicUdiDi>B-00847627003461</basicUdiDi>
    <tradeName>Mesothelin</tradeName>
    <deviceName>Mesothelin</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>ACI3175A</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:56:22.345Z</lastUpdated>
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    <udiDi>00847627024251</udiDi>
    <basicUdiDi>B-00847627024251</basicUdiDi>
    <tradeName>Microphtalmia Transcription Factor (MiTF)</tradeName>
    <deviceName>Microphtalmia Transcription Factor (MiTF)</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>AVI423G</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:40:09.017Z</lastUpdated>
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    <udiDi>00847627011954</udiDi>
    <basicUdiDi>B-00847627011954</basicUdiDi>
    <tradeName>Microphtalmia Transcription Factor (MiTF)</tradeName>
    <deviceName>Microphtalmia Transcription Factor (MiTF)</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>PM423AA</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:40:08.227Z</lastUpdated>
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    <udiDi>00847627007971</udiDi>
    <basicUdiDi>B-00847627007971</basicUdiDi>
    <tradeName>Microglia (Iba1)</tradeName>
    <deviceName>Microglia (Iba1)</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>CP290B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:40:07.430Z</lastUpdated>
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    <udiDi>00847627007964</udiDi>
    <basicUdiDi>B-00847627007964</basicUdiDi>
    <tradeName>Microglia (Iba1)</tradeName>
    <deviceName>Microglia (Iba1)</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>CP290A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:40:06.619Z</lastUpdated>
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    <udiDi>00847627007629</udiDi>
    <basicUdiDi>B-00847627007629</basicUdiDi>
    <tradeName>Microphtalmia Transcription Factor (MiTF)</tradeName>
    <deviceName>Microphtalmia Transcription Factor (MiTF)</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>CM423BK</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:40:01.830Z</lastUpdated>
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    <udiDi>00847627027054</udiDi>
    <basicUdiDi>B-00847627027054</basicUdiDi>
    <tradeName>CD137 [BLR051F]</tradeName>
    <deviceName>CD137 [BLR051F]</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>APR3264AA</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-05T14:09:00.067Z</lastUpdated>
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    <udiDi>00847627006677</udiDi>
    <basicUdiDi>B-00847627006677</basicUdiDi>
    <tradeName>CM167CK</tradeName>
    <deviceName>CD138</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>CD138</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-05T14:08:59.264Z</lastUpdated>
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    <udiDi>00847627006660</udiDi>
    <basicUdiDi>B-00847627006660</basicUdiDi>
    <tradeName>CD138</tradeName>
    <deviceName>CD138</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>CM167BK</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-05T14:08:58.464Z</lastUpdated>
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    <udiDi>00847627006653</udiDi>
    <basicUdiDi>B-00847627006653</basicUdiDi>
    <tradeName>CD138</tradeName>
    <deviceName>CD138</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>CM167AK</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-05T14:08:57.668Z</lastUpdated>
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    <udiDi>00847627004253</udiDi>
    <basicUdiDi>B-00847627004253</basicUdiDi>
    <tradeName>CD11c (Leu-M5)</tradeName>
    <deviceName>CD11c (Leu-M5)</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>API3122AA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-05T14:08:53.684Z</lastUpdated>
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    <basicUdiDi>B-00847627003133</basicUdiDi>
    <tradeName>CD11c (Leu-M5)</tradeName>
    <deviceName>CD11c (Leu-M5)</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACI3122B</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-05T14:08:52.873Z</lastUpdated>
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    <basicUdiDi>B-00847627024565</basicUdiDi>
    <tradeName>CD117/c-kit</tradeName>
    <deviceName>CD117/c-kit</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>OPAI296T60</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T22:22:35.813Z</lastUpdated>
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    <basicUdiDi>B-00847627011985</basicUdiDi>
    <tradeName>CD117/c-kit</tradeName>
    <deviceName>CD117/c-kit</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>PME296AA</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-04T22:22:34.995Z</lastUpdated>
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