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    <tradeName>IDS Specific IgE (D202) rDer p 1</tradeName>
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    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
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    <tradeName>IDS Specific IgE (D002) House dust mite</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
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    <tradeName>IDS Specific IgE (D001) House dust mite</tradeName>
    <deviceName>IDS Specific IgE (D001) House dust mite</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
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    <deviceName>AIA-PACK IgE SAMPLE DILUTING SOLUTION</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020595</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:42:06.070Z</lastUpdated>
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    <udiDi>04560189211070</udiDi>
    <basicUdiDi>B-04560189211070</basicUdiDi>
    <tradeName>04560189211070</tradeName>
    <deviceName>AIA-PACK IgEII CALIBRATOR SET</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020395</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:42:04.487Z</lastUpdated>
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    <udiDi>09120122920756</udiDi>
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    <tradeName>09120122920756</tradeName>
    <deviceName>ALEX Food</deviceName>
    <manufacturerName>MacroArray Diagnostics</manufacturerName>
    <manufacturerSrn>AT-MF-000030541</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07-5001-01</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:41:18.684Z</lastUpdated>
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    <deviceName>ALEX Air</deviceName>
    <manufacturerName>MacroArray Diagnostics</manufacturerName>
    <manufacturerSrn>AT-MF-000030541</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06-5001-01</reference>
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    <deviceName>ALEX³ Allergy Xplorer</deviceName>
    <manufacturerName>MacroArray Diagnostics</manufacturerName>
    <manufacturerSrn>AT-MF-000030541</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03-2001-01</reference>
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    <lastUpdated>2026-07-31T21:41:13.882Z</lastUpdated>
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    <deviceName>ALEX² Allergy Xplorer</deviceName>
    <manufacturerName>MacroArray Diagnostics</manufacturerName>
    <manufacturerSrn>AT-MF-000030541</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02-2001-01</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:41:13.077Z</lastUpdated>
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    <udiDi>08806133045473</udiDi>
    <basicUdiDi>880613300117BR</basicUdiDi>
    <tradeName>ichroma™ Total IgE</tradeName>
    <deviceName>ichroma™ Total IgE</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFPC-91</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:00:50.801Z</lastUpdated>
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    <udiDi>06942359547260</udiDi>
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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>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ0603</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:50:16.745Z</lastUpdated>
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    <udiDi>06944904032184</udiDi>
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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>105-002240-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:53:29.956Z</lastUpdated>
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    <udiDi>06925912735182</udiDi>
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    <tradeName>iMegaFlow-Allergen-sIgE tIgE</tradeName>
    <deviceName>iMegaFlow-Allergen-sIgE tIgE</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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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF001A1</reference>
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    <lastUpdated>2026-07-31T15:36:47.229Z</lastUpdated>
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    <tradeName>iFlash-Total IgE</tradeName>
    <deviceName>iFlash-Total IgE</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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    <tradeName>IgE ELISA</tradeName>
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    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <manufacturerName>AGNITIO SCIENCE &amp;TECHNOLOGY,INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000040942</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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