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    <tradeName>Wondfo Cancer Antigen 15-3 (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F106A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T04:52:09.769Z</lastUpdated>
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    <basicUdiDi>B-06971824203424</basicUdiDi>
    <tradeName>Wondfo Cancer Antigen 15-3 (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F106C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T04:52:09.260Z</lastUpdated>
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    <udiDi>06971824203431</udiDi>
    <basicUdiDi>B-06971824203431</basicUdiDi>
    <tradeName>Wondfo Cancer Antigen 15-3 (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F139A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T04:52:08.508Z</lastUpdated>
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    <udiDi>06971824203448</udiDi>
    <basicUdiDi>B-06971824203448</basicUdiDi>
    <tradeName>Wondfo Cancer Antigen 15-3 (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F139C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T04:52:07.813Z</lastUpdated>
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    <udiDi>06971824207712</udiDi>
    <basicUdiDi>B-06971824207712</basicUdiDi>
    <tradeName>Tisenc Procalcitonin (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>W116A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T04:51:48.868Z</lastUpdated>
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    <udiDi>06971824207729</udiDi>
    <basicUdiDi>B-06971824207729</basicUdiDi>
    <tradeName>Tisenc Procalcitonin (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>W116C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T04:50:53.051Z</lastUpdated>
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    <udiDi>06971824207736</udiDi>
    <basicUdiDi>B-06971824207736</basicUdiDi>
    <tradeName>Tisenc Procalcitonin (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>W04A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T04:50:14.685Z</lastUpdated>
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    <udiDi>06971824207743</udiDi>
    <basicUdiDi>B-06971824207743</basicUdiDi>
    <tradeName>Tisenc Procalcitonin (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>W04C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T03:36:31.672Z</lastUpdated>
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    <udiDi>06971824207750</udiDi>
    <basicUdiDi>B-06971824207750</basicUdiDi>
    <tradeName>Wondfo Procalcitonin (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>F116A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T03:36:31.396Z</lastUpdated>
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    <udiDi>06971824207767</udiDi>
    <basicUdiDi>B-06971824207767</basicUdiDi>
    <tradeName>Wondfo Procalcitonin (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>F116C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T03:36:31.187Z</lastUpdated>
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    <udiDi>06971824207774</udiDi>
    <basicUdiDi>B-06971824207774</basicUdiDi>
    <tradeName>Wondfo Procalcitonin (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>F04A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T03:36:31.083Z</lastUpdated>
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    <udiDi>06971824207781</udiDi>
    <basicUdiDi>B-06971824207781</basicUdiDi>
    <tradeName>Wondfo Procalcitonin (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>F04C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T03:36:30.912Z</lastUpdated>
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    <udiDi>06971824207552</udiDi>
    <basicUdiDi>B-06971824207552</basicUdiDi>
    <tradeName>Tisenc Folate (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>W119A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T03:36:30.786Z</lastUpdated>
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    <udiDi>06971824207569</udiDi>
    <basicUdiDi>B-06971824207569</basicUdiDi>
    <tradeName>Tisenc Folate (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>W119C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T03:36:30.156Z</lastUpdated>
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    <udiDi>06971824207576</udiDi>
    <basicUdiDi>B-06971824207576</basicUdiDi>
    <tradeName>Tisenc Folate (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>W03A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T03:36:29.938Z</lastUpdated>
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    <udiDi>06971824207583</udiDi>
    <basicUdiDi>B-06971824207583</basicUdiDi>
    <tradeName>Tisenc Folate (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>W03C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T03:34:49.212Z</lastUpdated>
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    <udiDi>06971824207590</udiDi>
    <basicUdiDi>B-06971824207590</basicUdiDi>
    <tradeName>Wondfo Folate (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>F119A</reference>
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    <lastUpdated>2026-09-22T03:34:48.489Z</lastUpdated>
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    <tradeName>Wondfo Folate (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>F119C</reference>
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    <lastUpdated>2026-09-22T03:34:48.216Z</lastUpdated>
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    <tradeName>Wondfo Folate (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>F03A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <tradeName>Wondfo Folate (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>F03C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T03:34:47.759Z</lastUpdated>
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