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    <tradeName>iFlash-Myoglobin</tradeName>
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    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
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    <tradeName>iFlash-Myoglobin</tradeName>
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    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
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    <udiDi>16977565581040</udiDi>
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    <tradeName>MYO (Myoglobin) Rapid Quantitative Test</tradeName>
    <deviceName>MYO (Myoglobin) Rapid Quantitative Test</deviceName>
    <manufacturerName>Coei Biotech Co.Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049509</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <deviceName>CL AIA-PACK Myoglobin ADJUSTER SET</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
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    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
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    <emdnDescription>MYOGLOBIN</emdnDescription>
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    <tradeName>14562185400370</tradeName>
    <deviceName>CL AIA-PACK Myoglobin TEST CUP</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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    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029133</reference>
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    <lastUpdated>2026-07-11T05:06:55.999Z</lastUpdated>
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    <udiDi>14560189210094</udiDi>
    <basicUdiDi>B-14560189210094</basicUdiDi>
    <tradeName>14560189210094</tradeName>
    <deviceName>ST AIA-PACK Myoglobin</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
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    <reference>0025297</reference>
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    <udiDi>D-11N86</udiDi>
    <basicUdiDi>B-11N86</basicUdiDi>
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    <deviceName>Myoglobin Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Shanghai Kehua Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026756</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <lastUpdated>2026-07-11T02:52:42.653Z</lastUpdated>
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    <udiDi>10850076346222</udiDi>
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    <tradeName>Myoglobin Test Kit (CLIA)</tradeName>
    <deviceName>Myoglobin Test Kit (CLIA)</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>MYOGLOBIN</emdnDescription>
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    <reference>CDMYO-401a</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
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    <udiDi>08809317540078</udiDi>
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    <tradeName>FREND Cardiac Triple</tradeName>
    <deviceName>FRCT 025</deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FRCT 025</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:41:54.395Z</lastUpdated>
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    <udiDi>06947145573812</udiDi>
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    <tradeName>Biossays Myoglobin (Latex Immunoturbidimetric)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130504010S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T03:44:59.787Z</lastUpdated>
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    <udiDi>06947145555702</udiDi>
    <basicUdiDi>69471455606WH</basicUdiDi>
    <tradeName>Biossays Myoglobin Calibrators</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160202606C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T03:44:57.347Z</lastUpdated>
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    <udiDi>06947145555719</udiDi>
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    <tradeName>Biossays Myoglobin Controls</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
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    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-10T03:44:57.303Z</lastUpdated>
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    <udiDi>06942359547512</udiDi>
    <basicUdiDi>697015090000035H3</basicUdiDi>
    <tradeName>MYO CLIA Microparticles</tradeName>
    <deviceName></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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMH0105</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:38:13.744Z</lastUpdated>
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    <udiDi>06979878281344</udiDi>
    <basicUdiDi>B-06979878281344</basicUdiDi>
    <tradeName>06979878281344</tradeName>
    <deviceName>Myoglobin 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>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001028</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:51:06.986Z</lastUpdated>
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    <basicUdiDi>B-06979469760913</basicUdiDi>
    <tradeName>Myoglobin (MYO) Test Kit (Quantum Dots Fluorescence Immunochromatography)</tradeName>
    <deviceName>Myoglobin (MYO) Test Kit (Quantum Dots Fluorescence Immunochromatography)</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A3402CC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:42:14.497Z</lastUpdated>
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    <tradeName>Myoglobin (MYO) Test Kit (Quantum Dots Fluorescence Immunochromatography)</tradeName>
    <deviceName>Myoglobin (MYO) Test Kit (Quantum Dots Fluorescence Immunochromatography)</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
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    <lastUpdated>2026-07-06T23:42:12.901Z</lastUpdated>
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    <tradeName>Myoglobin (MYO) Test Kit (Quantum Dots Fluorescence Immunochromatography)</tradeName>
    <deviceName>Myoglobin (MYO) Test Kit (Quantum Dots Fluorescence Immunochromatography)</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-06T23:42:10.495Z</lastUpdated>
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    <tradeName>Myoglobin (MYO) Test Kit (Quantum Dots Fluorescence Immunochromatography)</tradeName>
    <deviceName>Myoglobin (MYO) Test Kit (Quantum Dots Fluorescence Immunochromatography)</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
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    <reference>A3403CC</reference>
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    <lastUpdated>2026-07-06T23:42:08.890Z</lastUpdated>
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    <tradeName>Myoglobin (MYO) Test Kit (Quantum Dots Fluorescence Immunochromatography)</tradeName>
    <deviceName>Myoglobin (MYO) Test Kit (Quantum Dots Fluorescence Immunochromatography)</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
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    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-06T23:42:08.110Z</lastUpdated>
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    <tradeName>06979355928083</tradeName>
    <deviceName>Myoglobin (MYO) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit (including calibration and control)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:31:32.490Z</lastUpdated>
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