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    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
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    <lastUpdated>2026-07-31T15:35:55.950Z</lastUpdated>
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    <tradeName>iFlash-Sm IgG</tradeName>
    <deviceName>iFlash-Sm IgG</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-31T15:31:26.788Z</lastUpdated>
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    <tradeName>iFlash-Scl-70 IgG</tradeName>
    <deviceName>iFlash-Scl-70 IgG</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
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    <reference>C89013G</reference>
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    <lastUpdated>2026-07-31T15:31:19.569Z</lastUpdated>
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    <tradeName>iFlash-Jo-1 IgG</tradeName>
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    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
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    <lastUpdated>2026-07-31T15:31:17.963Z</lastUpdated>
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    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
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    <lastUpdated>2026-07-31T15:31:14.117Z</lastUpdated>
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    <tradeName>iFlash-GBM IgG</tradeName>
    <deviceName>iFlash-GBM IgG</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
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    <emdnDescription>ANTIBODIES TO GLOMERULAR BASAL MEMBRANE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C89002G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:31:11.614Z</lastUpdated>
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    <tradeName>BioCLIA Autoimmune Reagent Kit, Cardiolipin IgA</tradeName>
    <deviceName>BioCLIA Autoimmune Reagent Kit,BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control Set</deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY02197C</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:22:37.533Z</lastUpdated>
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    <tradeName>Theresa RUO Kit</tradeName>
    <deviceName>Theresa RUO kit</deviceName>
    <manufacturerName>Navolab Diagnosztika Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025337</manufacturerSrn>
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    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TK-0001</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:46:41.288Z</lastUpdated>
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    <tradeName>ASCA Screen IgA + IgG Dot</tradeName>
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    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0102109018</emdnCode>
    <emdnDescription>SACCHAROMYCES CEREVISIAE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD ASCASD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:04:18.157Z</lastUpdated>
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    <tradeName>BlueDiverDot Gastritis IgG</tradeName>
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    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-31T08:03:45.283Z</lastUpdated>
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    <tradeName>BlueDot Gastritis IgG</tradeName>
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    <lastUpdated>2026-07-31T08:03:24.481Z</lastUpdated>
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    <tradeName>SpermMar Test IgG antiserum</tradeName>
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    <lastUpdated>2026-07-31T07:59:56.934Z</lastUpdated>
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    <manufacturerName>MEDICAL &amp; BIOLOGICAL LABORATORIES CO., LTD.</manufacturerName>
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    <reference>7846E</reference>
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