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    <tradeName>AccuDiagTM Total Human IgE</tradeName>
    <deviceName>Total Human IgE ELISA Kit</deviceName>
    <manufacturerName>Diagnostic Automation/ Cortez Diagnostics, Inc.</manufacturerName>
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    <tradeName>Evo Total E</tradeName>
    <deviceName>Immunoenzymatic Kit for the determination of Total IgE Antibodies - Kit immunoenzimatico per la determinazione degli anticorpi IgE Totali</deviceName>
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    <tradeName>ImmunoCAP Total IgE Curve Control Strip</tradeName>
    <deviceName>ImmunoCAP Total IgE</deviceName>
    <manufacturerName>Phadia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000014170</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>ImmunoCAP Total IgE Conjugate 100</tradeName>
    <deviceName>ImmunoCAP Total IgE</deviceName>
    <manufacturerName>Phadia AB</manufacturerName>
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    <tradeName>ImmunoCAP Total IgE Anti-IgE</tradeName>
    <deviceName>ImmunoCAP Total IgE</deviceName>
    <manufacturerName>Phadia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000014170</manufacturerSrn>
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    <tradeName>ImmunoCAP Total IgE Low Range</tradeName>
    <deviceName>ImmunoCAP Total IgE Low Range</deviceName>
    <manufacturerName>Phadia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000014170</manufacturerSrn>
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    <lastUpdated>2026-07-03T01:15:03.249Z</lastUpdated>
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    <deviceName>iStar-Total IgE</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76106</reference>
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    <lastUpdated>2026-07-02T11:25:50.651Z</lastUpdated>
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    <tradeName>Immunoglobulin E Kit (Particle-enhanced Immunoturbidimetric Assay Method)</tradeName>
    <deviceName>Immunoglobulin E Kit (Particle-enhanced Immunoturbidimetric Assay Method)、IgE Calibrator</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-020853-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:42:01.790Z</lastUpdated>
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    <tradeName>IGE</tradeName>
    <deviceName>IGE</deviceName>
    <manufacturerName>Medicon Hellas SA</manufacturerName>
    <manufacturerSrn>GR-MF-000013625</manufacturerSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1418-0800</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:53:13.173Z</lastUpdated>
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    <tradeName>Total Immunoglobulin E (IgE)</tradeName>
    <deviceName>Total Immunoglobulin E (IgE)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C22529</reference>
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    <lastUpdated>2026-07-01T08:39:19.068Z</lastUpdated>
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    <tradeName>tIgE CLIA Microparticles</tradeName>
    <deviceName>tIgE CLIA Microparticles</deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
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    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ0602</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:46:12.292Z</lastUpdated>
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    <tradeName>MAGICL IgE (CLIA)</tradeName>
    <deviceName>MAGICL IgE (CLIA)</deviceName>
    <manufacturerName>Getein Biotech, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017986</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-28T15:33:08.472Z</lastUpdated>
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    <tradeName>Total IgE Fast Test Kit (Immunofluorescence Assay)</tradeName>
    <deviceName>Total IgE Fast Test Kit (Immunofluorescence Assay)</deviceName>
    <manufacturerName>Getein Biotech, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017986</manufacturerSrn>
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    <tradeName>Total IgE (CLIA)</tradeName>
    <deviceName>Total IgE (CLIA)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
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    <tradeName>Total IgE (CLIA)</tradeName>
    <deviceName>Total IgE (CLIA)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
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    <tradeName>Total IgE (CLIA)</tradeName>
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    <tradeName>Total IgE (CLIA)</tradeName>
    <deviceName>Total IgE (CLIA)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
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    <tradeName>Immunoglobulin E (IgE) Detection Kit (Nephelometry)</tradeName>
    <deviceName>Immunoglobulin E (IgE) Detection Kit (Nephelometry)</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
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    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <reference>32027218</reference>
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