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    <tradeName>Wondfo Myoglobin (CLIA)</tradeName>
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    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <basicUdiDi>B-06971824206999</basicUdiDi>
    <tradeName>Tisenc Creatine Kinase-MB (CLIA)</tradeName>
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    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription></emdnDescription>
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    <basicUdiDi>B-06971824207002</basicUdiDi>
    <tradeName>Tisenc Creatine Kinase-MB (CLIA)</tradeName>
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    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
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    <tradeName>Tisenc Creatine Kinase-MB (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription></emdnDescription>
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    <basicUdiDi>B-06971824207026</basicUdiDi>
    <tradeName>Tisenc Creatine Kinase-MB (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <basicUdiDi>B-06971824207033</basicUdiDi>
    <tradeName>Wondfo Creatine Kinase-MB (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription></emdnDescription>
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    <basicUdiDi>B-06971824207040</basicUdiDi>
    <tradeName>Wondfo Creatine Kinase-MB (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription></emdnDescription>
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    <lastUpdated>2026-09-22T01:01:54.288Z</lastUpdated>
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    <basicUdiDi>B-06971824207057</basicUdiDi>
    <tradeName>Wondfo Creatine Kinase-MB (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-09-22T01:01:50.567Z</lastUpdated>
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    <tradeName>Wondfo Creatine Kinase-MB (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F11C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T01:01:38.172Z</lastUpdated>
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    <basicUdiDi>B-06971824208436</basicUdiDi>
    <tradeName>Tisenc D-Dimer (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W128A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T01:01:36.309Z</lastUpdated>
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    <basicUdiDi>B-06971824208443</basicUdiDi>
    <tradeName>Tisenc D-Dimer (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W128C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T01:01:33.496Z</lastUpdated>
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    <basicUdiDi>B-06971824208450</basicUdiDi>
    <tradeName>Tisenc D-Dimer (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W13A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T01:01:01.396Z</lastUpdated>
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    <tradeName>Tisenc D-Dimer (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-09-22T01:00:59.991Z</lastUpdated>
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    <basicUdiDi>B-06971824208474</basicUdiDi>
    <tradeName>Wondfo D-Dimer (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-09-22T01:00:58.694Z</lastUpdated>
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    <basicUdiDi>B-06971824208481</basicUdiDi>
    <tradeName>Wondfo D-Dimer (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
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    <tradeName>Wondfo D-Dimer (CLIA)</tradeName>
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    <tradeName>Wondfo D-Dimer (CLIA)</tradeName>
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    <tradeName>Tisenc Heart-type Fatty Acid-binding Protein (CLIA)</tradeName>
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    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Tisenc Heart-type Fatty Acid-binding Protein (CLIA)</tradeName>
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    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
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    <tradeName>Tisenc Heart-type Fatty Acid-binding Protein (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W14A</reference>
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