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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>Tisenc Carbohydrate Antigen 19-9 (CLIA)</tradeName>
    <deviceName>Carbohydrate Antigen 19-9 (CLIA)</deviceName>
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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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    <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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    <emdnDescription>OTHER INTERLEUKINS (EXCEPT FOR IL-6)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:48:37.544Z</lastUpdated>
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    <basicUdiDi>B-06971824209204</basicUdiDi>
    <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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    <emdnDescription>OTHER INTERLEUKINS (EXCEPT FOR IL-6)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:48:36.739Z</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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    <emdnDescription>OTHER INTERLEUKINS (EXCEPT FOR IL-6)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
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    <tradeName>Tisenc 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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    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:48:35.159Z</lastUpdated>
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    <tradeName>Tisenc 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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    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:48:31.158Z</lastUpdated>
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    <basicUdiDi>B-06971824209044</basicUdiDi>
    <tradeName>Wondfo Carcinoembryonic Antigen (CLIA)</tradeName>
    <deviceName>Carcinoembryonic Antigen (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>
    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F85C</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:48:30.336Z</lastUpdated>
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    <basicUdiDi>B-06971824209037</basicUdiDi>
    <tradeName>Wondfo Carcinoembryonic Antigen (CLIA)</tradeName>
    <deviceName>Carcinoembryonic Antigen (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>
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    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F85A</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:48:29.549Z</lastUpdated>
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    <basicUdiDi>B-06971824209020</basicUdiDi>
    <tradeName>Tisenc Carcinoembryonic Antigen (CLIA)</tradeName>
    <deviceName>Carcinoembryonic Antigen (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>
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    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W141C</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:48:28.752Z</lastUpdated>
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    <basicUdiDi>B-06971824209013</basicUdiDi>
    <tradeName>Tisenc Carcinoembryonic Antigen (CLIA)</tradeName>
    <deviceName>Carcinoembryonic Antigen (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>
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    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W141A</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:48:24.732Z</lastUpdated>
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    <udiDi>06971824209006</udiDi>
    <basicUdiDi>B-06971824209006</basicUdiDi>
    <tradeName>Tisenc Carcinoembryonic Antigen (CLIA)</tradeName>
    <deviceName>Carcinoembryonic Antigen (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>
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    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W85C</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-08-12T20:48:23.937Z</lastUpdated>
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    <udiDi>06971824208993</udiDi>
    <basicUdiDi>B-06971824208993</basicUdiDi>
    <tradeName>Tisenc Carcinoembryonic Antigen (CLIA)</tradeName>
    <deviceName>Carcinoembryonic Antigen (CLIA)</deviceName>
    <manufacturerName>Shenzhen Tisenc Medical Devices Co., Ltd.</manufacturerName>
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    <reference>W85A</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
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    <tradeName>Tisenc Interleukin-6 (CLIA)</tradeName>
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    <tradeName>Tisenc Interleukin-6 (CLIA)</tradeName>
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