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    <deviceName>Heart-type Fatty Acid-Binding Protein (H-FABP) Assay Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Shenzhen AmTech Bioengineering Ltd., Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000043067</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×60 mL, R2: 2×15 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:40:03.406Z</lastUpdated>
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    <basicUdiDi>B-06974738205164</basicUdiDi>
    <tradeName>Heart-Type Fatty Acid-Binding Protein Rapid Test Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Fluorescence Immunochromatography Analyzer</deviceName>
    <manufacturerName>Hoyotek Biomedical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003570</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
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    <basicUdiDi>B-06974738205157</basicUdiDi>
    <tradeName>Heart-Type Fatty Acid-Binding Protein Rapid Test Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Fluorescence Immunochromatography Analyzer</deviceName>
    <manufacturerName>Hoyotek Biomedical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003570</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:38:10.381Z</lastUpdated>
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    <udiDi>06974674892688</udiDi>
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    <tradeName>Human Heart Fatty Acid Binding Protein (H-FABP) Detection Kit(CLIA)</tradeName>
    <deviceName>Human Heart Fatty Acid Binding Protein (H-FABP) Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021302</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID BINDING PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0140</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:16:51.845Z</lastUpdated>
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    <udiDi>06974674892275</udiDi>
    <basicUdiDi>B-06974674892275</basicUdiDi>
    <tradeName>H-FABP FIA Kit</tradeName>
    <deviceName>H-FABP FIA Kit</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021302</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID BINDING PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0057</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:14:00.948Z</lastUpdated>
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    <udiDi>06974671101899</udiDi>
    <basicUdiDi>B-06974671101899</basicUdiDi>
    <tradeName>06974671101899</tradeName>
    <deviceName>Cardiac Fatty Acid Binding Protein Quantitative Diagnostic Kit (CLIA)</deviceName>
    <manufacturerName>Darui Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030310</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021302</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID BINDING PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR-CLIA-CK-A040</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:10:15.372Z</lastUpdated>
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    <udiDi>06974566303360</udiDi>
    <basicUdiDi>B-06974566303360</basicUdiDi>
    <tradeName>h-FABP  Rapid Test</tradeName>
    <deviceName>h-FABP  Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021302</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID BINDING PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFA-402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:56:44.736Z</lastUpdated>
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    <basicUdiDi>B-06974521004196</basicUdiDi>
    <tradeName>H-FABP Assay kit CLIA</tradeName>
    <deviceName>H-FABP Assay kit CLIA</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021302</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID BINDING PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPM075072</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:38:04.720Z</lastUpdated>
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    <udiDi>06974521004189</udiDi>
    <basicUdiDi>B-06974521004189</basicUdiDi>
    <tradeName>H-FABP Assay kit CLIA</tradeName>
    <deviceName>H-FABP Assay kit CLIA</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021302</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID BINDING PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPM075036</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:38:03.131Z</lastUpdated>
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    <udiDi>06974473302531</udiDi>
    <basicUdiDi>B-06974473302531</basicUdiDi>
    <tradeName>H-FABP Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)</tradeName>
    <deviceName>H-FABP Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021302</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID BINDING PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W01021302</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:10:24.627Z</lastUpdated>
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    <udiDi>06974323013334</udiDi>
    <basicUdiDi>B-06974323013334</basicUdiDi>
    <tradeName>06974323013334</tradeName>
    <deviceName>H-FABP rapid test cassette (Rare earth nano fluorescence immunochromatography)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021302</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID BINDING PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IF022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:53:25.883Z</lastUpdated>
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    <udiDi>06974323013327</udiDi>
    <basicUdiDi>B-06974323013327</basicUdiDi>
    <tradeName>06974323013327</tradeName>
    <deviceName>H-FABP rapid test cassette (Rare earth nano fluorescence immunochromatography)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021302</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID BINDING PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IF022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:53:25.213Z</lastUpdated>
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    <basicUdiDi>B-06974323013310</basicUdiDi>
    <tradeName>06974323013310</tradeName>
    <deviceName>H-FABP rapid test cassette (Rare earth nano fluorescence immunochromatography)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021302</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID BINDING PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IF022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:53:24.283Z</lastUpdated>
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    <udiDi>06973861684198</udiDi>
    <basicUdiDi>B-06973861684198</basicUdiDi>
    <tradeName>H-FABP Rapid Test Kit</tradeName>
    <deviceName>H-FABP Rapid Test Kit</deviceName>
    <manufacturerName>Anbio (Xiamen) Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023936</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021302</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID BINDING PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02046002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:43:15.099Z</lastUpdated>
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    <tradeName>06972719605859</tradeName>
    <deviceName>Heart-type Fatty Acid Binding Protein Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W01021302</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID BINDING PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:51:09.786Z</lastUpdated>
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    <tradeName>06972719605842</tradeName>
    <deviceName>Heart-type Fatty Acid Binding Protein Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W01021302</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID BINDING PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:51:09.009Z</lastUpdated>
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    <basicUdiDi>B-06972719605835</basicUdiDi>
    <tradeName>06972719605835</tradeName>
    <deviceName>Heart-type Fatty Acid Binding Protein Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <emdnCode>W01021302</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID BINDING PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:51:07.381Z</lastUpdated>
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    <basicUdiDi>B-06972719605828</basicUdiDi>
    <tradeName>06972719605828</tradeName>
    <deviceName>Heart-type Fatty Acid Binding Protein Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021302</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID BINDING PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:51:04.991Z</lastUpdated>
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    <basicUdiDi>B-06971674869870</basicUdiDi>
    <tradeName>Heart-type Fatty Acid-Binding Protein (H-FABP) Assay Kit （Latex Immunoturbidimetric）</tradeName>
    <deviceName>Heart-type Fatty Acid-Binding Protein (H-FABP) Assay Kit （Latex Immunoturbidimetric）</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021302</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID BINDING PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:20mL×1  R2:20mL×1（702）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:44:20.571Z</lastUpdated>
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    <basicUdiDi>B-06971674869863</basicUdiDi>
    <tradeName>Heart-type Fatty Acid-Binding Protein (H-FABP) Assay Kit （Latex Immunoturbidimetric）</tradeName>
    <deviceName>Heart-type Fatty Acid-Binding Protein (H-FABP) Assay Kit （Latex Immunoturbidimetric）</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021302</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID BINDING PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:20mL×4  R2:20mL×4（709）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:44:19.026Z</lastUpdated>
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