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    <tradeName>iFlash-IgG2</tradeName>
    <deviceName></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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86087G-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:11.033Z</lastUpdated>
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    <udiDi>06925912721246</udiDi>
    <basicUdiDi>692591270262HH</basicUdiDi>
    <tradeName>iFlash-IgG3</tradeName>
    <deviceName></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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86088G-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:10.991Z</lastUpdated>
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    <udiDi>06925912721253</udiDi>
    <basicUdiDi>692591270248HP</basicUdiDi>
    <tradeName>iFlash-IgG4</tradeName>
    <deviceName></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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86089G-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:10.972Z</lastUpdated>
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    <udiDi>06975070768874</udiDi>
    <basicUdiDi>B-06975070768874</basicUdiDi>
    <tradeName>Sharay IgG (CLIA)</tradeName>
    <deviceName>Sharay IgG (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>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000839</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:49:51.798Z</lastUpdated>
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    <udiDi>06975070768867</udiDi>
    <basicUdiDi>B-06975070768867</basicUdiDi>
    <tradeName>Sharay IgG (CLIA)</tradeName>
    <deviceName>Sharay IgG (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>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000398</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:49:50.996Z</lastUpdated>
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    <udiDi>06975070768850</udiDi>
    <basicUdiDi>B-06975070768850</basicUdiDi>
    <tradeName>Sharay IgG (CLIA)</tradeName>
    <deviceName>Sharay IgG (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>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000837</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:49:35.709Z</lastUpdated>
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    <udiDi>06975070768843</udiDi>
    <basicUdiDi>B-06975070768843</basicUdiDi>
    <tradeName>Sharay IgG (CLIA)</tradeName>
    <deviceName>Sharay IgG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000836</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:49:31.733Z</lastUpdated>
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    <udiDi>06975070766146</udiDi>
    <basicUdiDi>B-06975070766146</basicUdiDi>
    <tradeName>Sharay IgG (CLIA)</tradeName>
    <deviceName>Sharay IgG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000401</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:43:05.538Z</lastUpdated>
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    <udiDi>06975070766139</udiDi>
    <basicUdiDi>B-06975070766139</basicUdiDi>
    <tradeName>Sharay IgG (CLIA)</tradeName>
    <deviceName>Sharay IgG (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>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000400</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:43:01.533Z</lastUpdated>
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    <udiDi>06975070766122</udiDi>
    <basicUdiDi>B-06975070766122</basicUdiDi>
    <tradeName>Sharay IgG (CLIA)</tradeName>
    <deviceName>Sharay IgG (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>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000399</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:43:00.743Z</lastUpdated>
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    <udiDi>06975070766115</udiDi>
    <basicUdiDi>B-06975070766115</basicUdiDi>
    <tradeName>Sharay IgG (CLIA)</tradeName>
    <deviceName>Sharay IgG (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>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000398</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:42:59.932Z</lastUpdated>
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    <udiDi>06972719607068</udiDi>
    <basicUdiDi>B-06972719607068</basicUdiDi>
    <tradeName>06972719607068</tradeName>
    <deviceName>Immunoglobulin G4 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:56:19.819Z</lastUpdated>
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    <udiDi>06972719607051</udiDi>
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    <tradeName>06972719607051</tradeName>
    <deviceName>Immunoglobulin G4 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:56:18.220Z</lastUpdated>
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    <tradeName>06972719606221</tradeName>
    <deviceName>Immunoglobulin G4 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:52:11.498Z</lastUpdated>
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    <tradeName>06972719606214</tradeName>
    <deviceName>Immunoglobulin G4 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:52:10.686Z</lastUpdated>
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    <tradeName>06972719606207</tradeName>
    <deviceName>Immunoglobulin G4 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
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    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:52:06.690Z</lastUpdated>
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    <tradeName>06972719606191</tradeName>
    <deviceName>Immunoglobulin G4 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
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    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:52:05.906Z</lastUpdated>
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    <tradeName>06971763220575</tradeName>
    <deviceName>IgG4 Test Kit (Dry Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Lansion Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001086</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0057-03</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:47:15.091Z</lastUpdated>
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    <udiDi>08058945155745</udiDi>
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    <tradeName>Evo Specific G4</tradeName>
    <deviceName>Immunoenzymatic Kit for the determination of Specific IgG4 Antibodies - Kit immunoenzimatico per la determinazione degli anticorpi IgG4 Specifici</deviceName>
    <manufacturerName>ABD SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000029729</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N1000G4</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:15:51.506Z</lastUpdated>
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    <udiDi>07333066022796</udiDi>
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    <tradeName>ImmunoCAP Specific IgG4 Calibrator Strip</tradeName>
    <deviceName>ImmunoCAP Specific IgG4</deviceName>
    <manufacturerName>Phadia AB</manufacturerName>
    <manufacturerSrn>SE-MF-000014170</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010106</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G SUBCLASS REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10-9550-01</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:18:22.666Z</lastUpdated>
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