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    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
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    <tradeName>Tisenc Alpha-fetoprotein (CLIA)</tradeName>
    <deviceName>Alpha-fetoprotein (CLIA)</deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
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    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
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    <tradeName>Wondfo Cancer Antigen 125 (CLIA)</tradeName>
    <deviceName>Cancer Antigen 125 (CLIA)</deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <tradeName>Wondfo Cancer Antigen 125 (CLIA)</tradeName>
    <deviceName>Cancer Antigen 125 (CLIA)</deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <basicUdiDi>B-06971824208887</basicUdiDi>
    <tradeName>Wondfo Cancer Antigen 125 (CLIA)</tradeName>
    <deviceName>Cancer Antigen 125 (CLIA)</deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F104C</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
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    <tradeName>Wondfo Cancer Antigen 125 (CLIA)</tradeName>
    <deviceName>Cancer Antigen 125 (CLIA)</deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
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    <basicUdiDi>B-06971824208863</basicUdiDi>
    <tradeName>Tisenc Cancer Antigen 125 (CLIA)</tradeName>
    <deviceName>Cancer Antigen 125 (CLIA)</deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
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    <tradeName>Tisenc Cancer Antigen 125 (CLIA)</tradeName>
    <deviceName>Cancer Antigen 125 (CLIA)</deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
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    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:48:34.243Z</lastUpdated>
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    <tradeName>Tisenc Cancer Antigen 125 (CLIA)</tradeName>
    <deviceName>Cancer Antigen 125 (CLIA)</deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W104C</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:48:30.291Z</lastUpdated>
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    <udiDi>06971824208832</udiDi>
    <basicUdiDi>B-06971824208832</basicUdiDi>
    <tradeName>Tisenc Cancer Antigen 125 (CLIA)</tradeName>
    <deviceName>Cancer Antigen 125 (CLIA)</deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
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    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W104A</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:48:29.434Z</lastUpdated>
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    <basicUdiDi>B-06971824208788</basicUdiDi>
    <tradeName>Tisenc Carbohydrate Antigen 19-9 (CLIA)</tradeName>
    <deviceName>Carbohydrate Antigen 19-9 (CLIA)</deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W138C</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:48:28.655Z</lastUpdated>
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    <tradeName>Tisenc Carbohydrate Antigen 19-9 (CLIA)</tradeName>
    <deviceName>Carbohydrate Antigen 19-9 (CLIA)</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>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>W138A</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:48:27.831Z</lastUpdated>
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    <tradeName>Tisenc Carbohydrate Antigen 19-9 (CLIA)</tradeName>
    <deviceName>Carbohydrate Antigen 19-9 (CLIA)</deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W105C</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:48:23.851Z</lastUpdated>
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    <tradeName>Tisenc Carbohydrate Antigen 19-9 (CLIA)</tradeName>
    <deviceName>Carbohydrate Antigen 19-9 (CLIA)</deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>W105A</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-08-13T03:48:23.029Z</lastUpdated>
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    <tradeName>Wondfo Interleukin-6 (CLIA)</tradeName>
    <deviceName>Interleukin-6 (CLIA)</deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>F142C</reference>
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    <lastUpdated>2026-08-12T20:48:41.556Z</lastUpdated>
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    <tradeName>Wondfo Interleukin-6 (CLIA)</tradeName>
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    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
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    <tradeName>Wondfo Interleukin-6 (CLIA)</tradeName>
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    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <tradeName>Wondfo Interleukin-6 (CLIA)</tradeName>
    <deviceName>Interleukin-6 (CLIA)</deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
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    <reference>F90A</reference>
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    <tradeName>Tisenc Interleukin-6 (CLIA)</tradeName>
    <deviceName>Interleukin-6 (CLIA)</deviceName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>W142C</reference>
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    <tradeName>Tisenc Interleukin-6 (CLIA)</tradeName>
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    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022936</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>W142A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:48:31.158Z</lastUpdated>
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