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    <manufacturerName>Biocare Medical</manufacturerName>
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    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <basicUdiDi>B-00847627006257</basicUdiDi>
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    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM123A</reference>
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    <deviceName>Breast Cocktail(CKHMW/p63+CK7/8/18)</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVI3203DSKG</reference>
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    <lastUpdated>2026-08-01T17:39:52.972Z</lastUpdated>
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    <tradeName>CD103 (RM)</tradeName>
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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>API3117AA</reference>
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    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
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    <reference>ACI3117B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
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    <deviceName>CD103 (RM)</deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACI3117A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-01T17:39:47.349Z</lastUpdated>
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    <udiDi>06925912734314</udiDi>
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    <tradeName>iFlash-Total β HCG</tradeName>
    <deviceName>iFlash-Total β HCG</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86327-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:36:24.780Z</lastUpdated>
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    <udiDi>15099590216733</udiDi>
    <basicUdiDi>150995905PRLIRMAZK</basicUdiDi>
    <tradeName>Prolactin IRMA KIT</tradeName>
    <deviceName>Prolactin IRMA KIT</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM2121</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:44:25.581Z</lastUpdated>
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    <udiDi>15099590214661</udiDi>
    <basicUdiDi>150995905AFPIRMAN4</basicUdiDi>
    <tradeName>AFP IRMA KIT</tradeName>
    <deviceName>AFP IRMA KIT</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM1441</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:43:42.301Z</lastUpdated>
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    <udiDi>15099590213107</udiDi>
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    <tradeName>RIA DHEA Sulfate</tradeName>
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    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM0729</reference>
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    <lastUpdated>2026-07-30T17:43:23.892Z</lastUpdated>
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    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0102039099</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSL2700</reference>
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    <lastUpdated>2026-07-30T17:42:47.018Z</lastUpdated>
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    <tradeName>Inhibin B Gen II ELISA</tradeName>
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    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
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    <reference>A81303</reference>
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