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    <tradeName>RapidFor™ Total IgE Rapid Test Kit (FIA)</tradeName>
    <deviceName>Total IgE Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO79</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:14:37.496Z</lastUpdated>
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    <udiDi>08681812532433</udiDi>
    <basicUdiDi>B-08681812532433</basicUdiDi>
    <tradeName>IgE TÜRBİDİMETRİK KİTİ</tradeName>
    <deviceName>IGE TURBIDIMETRIC REAGENT</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
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    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
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    <udiDi>08681812532426</udiDi>
    <basicUdiDi>B-08681812532426</basicUdiDi>
    <tradeName>IgE TÜRBİDİMETRİK KİTİ</tradeName>
    <deviceName>IGE TURBIDIMETRIC REAGENT</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
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    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:41:56.772Z</lastUpdated>
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    <udiDi>08053172971984</udiDi>
    <basicUdiDi>B-08053172971984</basicUdiDi>
    <tradeName>IgE</tradeName>
    <deviceName>IgE</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6726</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:47:48.672Z</lastUpdated>
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    <udiDi>08034049110606</udiDi>
    <basicUdiDi>B-08034049110606</basicUdiDi>
    <tradeName>08034049110606</tradeName>
    <deviceName>IgE Total ELISA</deviceName>
    <manufacturerName>Dia.Metra Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000027206</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DKO060</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T15:01:36.206Z</lastUpdated>
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    <udiDi>06980070460079</udiDi>
    <basicUdiDi>B-06980070460079</basicUdiDi>
    <tradeName>Sharay Dust Mite Allergen Components sIgG4 (CLIA)</tradeName>
    <deviceName>Sharay Dust Mite Allergen Components sIgG4 (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020202</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000939</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:53:12.931Z</lastUpdated>
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    <udiDi>06979878281177</udiDi>
    <basicUdiDi>B-06979878281177</basicUdiDi>
    <tradeName>06979878281177</tradeName>
    <deviceName>IgE Test (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Huzhou Jierunxin Biotechnology Co., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000047637</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001015</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:50:27.713Z</lastUpdated>
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    <udiDi>06978198482257</udiDi>
    <basicUdiDi>B-06978198482257</basicUdiDi>
    <tradeName>Total Immunoglobulin E (TIgE) Test Kit (Immunofluorescence)</tradeName>
    <deviceName>Total Immunoglobulin E (TIgE) Test Kit (Immunofluorescence)</deviceName>
    <manufacturerName>Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046524</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2225</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:43:04.570Z</lastUpdated>
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    <udiDi>06977903346624</udiDi>
    <basicUdiDi>B-06977903346624</basicUdiDi>
    <tradeName>06977903346624</tradeName>
    <deviceName>FA FIA</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS121104C25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:36:48.007Z</lastUpdated>
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    <udiDi>06977903346617</udiDi>
    <basicUdiDi>B-06977903346617</basicUdiDi>
    <tradeName>06977903346617</tradeName>
    <deviceName>FA FIA</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS121104C01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:36:47.208Z</lastUpdated>
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    <udiDi>06977903345825</udiDi>
    <basicUdiDi>B-06977903345825</basicUdiDi>
    <tradeName>06977903345825</tradeName>
    <deviceName>IgE FIA</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS121201C25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:36:20.793Z</lastUpdated>
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    <udiDi>06977903345818</udiDi>
    <basicUdiDi>B-06977903345818</basicUdiDi>
    <tradeName>06977903345818</tradeName>
    <deviceName>IgE FIA</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS121201C01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:36:20.004Z</lastUpdated>
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    <udiDi>06977565583849</udiDi>
    <basicUdiDi>B-06977565583849</basicUdiDi>
    <tradeName>Total IgE Rapid Quantitative Test</tradeName>
    <deviceName>Total IgE Rapid Quantitative Test</deviceName>
    <manufacturerName>Coei Biotech Co.Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049509</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3842</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:22:22.094Z</lastUpdated>
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    <udiDi>06976753478462</udiDi>
    <basicUdiDi>B-06976753478462</basicUdiDi>
    <tradeName>Total Immunoglobulin E (Total IgE) Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KF001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:02:08.508Z</lastUpdated>
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    <udiDi>06976612387041</udiDi>
    <basicUdiDi>B-06976612387041</basicUdiDi>
    <tradeName>06976612387041</tradeName>
    <deviceName>QD-FAST Food IgG Test Kit</deviceName>
    <manufacturerName>Jinan Deheng Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048173</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020208</emdnCode>
    <emdnDescription>ALLERGENE SPECIFIC IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Panel 1 1 test/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:54:04.333Z</lastUpdated>
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    <udiDi>06976612386006</udiDi>
    <basicUdiDi>B-06976612386006</basicUdiDi>
    <tradeName>06976612386006</tradeName>
    <deviceName>QD-FAST Allergen Test Kit</deviceName>
    <manufacturerName>Jinan Deheng Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048173</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IgE 1 test/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:54:03.533Z</lastUpdated>
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    <udiDi>06976117455016</udiDi>
    <basicUdiDi>B-06976117455016</basicUdiDi>
    <tradeName>Total IgE Antibody Assay（Fluorescence flow cytometry）</tradeName>
    <deviceName>Total IgE Antibody Assay（Fluorescence flow cytometry）</deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY-0017-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:32:30.920Z</lastUpdated>
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    <basicUdiDi>B-06976117455009</basicUdiDi>
    <tradeName>Allergen-Specific IgE Antibody Calibrator Kit (Fluorescence flow cytometry)</tradeName>
    <deviceName>Allergen-Specific IgE Antibody Calibrator Kit (Fluorescence flow cytometry)</deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
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    <emdnDescription>IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY-0018-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:32:29.317Z</lastUpdated>
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    <basicUdiDi>B-06976117454965</basicUdiDi>
    <tradeName>Allergen-Specific lgE Antibody Quality Control</tradeName>
    <deviceName>Allergen-Specific lgE Antibody Quality Control</deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
    <emdnCode>W01020204</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY-0031-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:32:22.915Z</lastUpdated>
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    <basicUdiDi>B-06976117454910</basicUdiDi>
    <tradeName>Total IgE Antibody Quality Control</tradeName>
    <deviceName>Total IgE Antibody Quality Control</deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY-0019-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:32:16.509Z</lastUpdated>
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