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    <deviceName>Pepsinogen I/II Diagnostic Kit (TRFIA)</deviceName>
    <manufacturerName>Darui Biotechnology Co., Ltd.</manufacturerName>
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    <tradeName>PCT-Quantitative Rapid Test</tradeName>
    <deviceName>PCT-Quantitative Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <tradeName>Procalcitonin (PCT) Test Kit (Homogeneous Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Procalcitonin (PCT) Test Kit (Homogeneous Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Nanjing Poclight Biotechnology Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>HUMISS TRADING S. L.</authorisedRepresentativeName>
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    <tradeName>PGⅡ Assay kit CLIA</tradeName>
    <deviceName>PGⅡ Assay kit CLIA</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <basicUdiDi>B-06974521004288</basicUdiDi>
    <tradeName>PGⅡ Assay kit CLIA</tradeName>
    <deviceName>PGⅡ Assay kit CLIA</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <basicUdiDi>B-06974521004271</basicUdiDi>
    <tradeName>PGⅠ Assay kit CLIA</tradeName>
    <deviceName>PGⅠ Assay kit CLIA</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>PGⅠ Assay kit CLIA</tradeName>
    <deviceName>PGⅠ Assay kit CLIA</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
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    <tradeName>W0102069013</tradeName>
    <deviceName>PCT Assay Kit CLIA</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPM042072</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:30:57.829Z</lastUpdated>
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    <tradeName>PCT Assay Kit CLIA</tradeName>
    <deviceName>PCT Assay Kit CLIA</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPM042036</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:30:57.023Z</lastUpdated>
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    <udiDi>06974521000709</udiDi>
    <basicUdiDi>B-06974521000709</basicUdiDi>
    <tradeName>Diagnostic Kit for Procalcitonin (PCT) (Time-resolved Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Diagnostic Kit for Procalcitonin (PCT) (Time-resolved Fluorescence Immunochromatographic Assay)</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>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPF007025</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:27:55.898Z</lastUpdated>
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    <udiDi>06974473308441</udiDi>
    <basicUdiDi>B-06974473308441</basicUdiDi>
    <tradeName>PCT Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)</tradeName>
    <deviceName>PCT 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>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XJ004</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:12:08.791Z</lastUpdated>
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    <udiDi>06974473307598</udiDi>
    <basicUdiDi>B-06974473307598</basicUdiDi>
    <tradeName>G17 Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)</tradeName>
    <deviceName>G17 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>W0102069001</emdnCode>
    <emdnDescription>GASTRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WC002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:11:55.178Z</lastUpdated>
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    <udiDi>06974473300285</udiDi>
    <basicUdiDi>B-06974473300285</basicUdiDi>
    <tradeName>PGI/PGII Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)</tradeName>
    <deviceName>PGI/PGII 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>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CW001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:09:52.623Z</lastUpdated>
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    <udiDi>06974464591395</udiDi>
    <basicUdiDi>B-06974464591395</basicUdiDi>
    <tradeName>Procalcitonin (PCT) Rapid Test Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Procalcitonin (PCT) Rapid Test Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Guangzhou Decheng Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013536</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>5074C4X025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:08:58.916Z</lastUpdated>
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    <basicUdiDi>B-06974323018377</basicUdiDi>
    <tradeName>06974323018377</tradeName>
    <deviceName>Human Chorionic Gonadotropin (HCG) Rapid Test Cassette (Colloidal Gold Method)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <lastUpdated>2026-07-06T16:01:57.886Z</lastUpdated>
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    <tradeName>06974323018360</tradeName>
    <deviceName>Human Chorionic Gonadotropin (HCG) Rapid Test Cassette (Colloidal Gold Method)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
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    <tradeName>06974323018353</tradeName>
    <deviceName>Human Chorionic Gonadotropin (HCG) Rapid Test Cassette (Colloidal Gold Method)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <deviceName>PG I/PG II rapid test cassette (Rare earth nano fluorescence immunochromatography)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
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    <lastUpdated>2026-07-06T15:56:12.609Z</lastUpdated>
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    <deviceName>PG I/PG II rapid test cassette (Rare earth nano fluorescence immunochromatography)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <deviceName>PG I/PG II rapid test cassette (Rare earth nano fluorescence immunochromatography)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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