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    <basicUdiDi>B-06977846952654</basicUdiDi>
    <tradeName>Tumor Companion Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangxi CellGene Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055358</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E020400402</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T07:44:13.431Z</lastUpdated>
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    <udiDi>06977846952661</udiDi>
    <basicUdiDi>B-06977846952661</basicUdiDi>
    <tradeName>Tumor Companion Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangxi CellGene Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055358</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E020400403</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T07:44:13.214Z</lastUpdated>
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    <udiDi>06977846952678</udiDi>
    <basicUdiDi>B-06977846952678</basicUdiDi>
    <tradeName>Tumor Companion Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangxi CellGene Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055358</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E020400404</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T07:44:13.171Z</lastUpdated>
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    <udiDi>06977846952685</udiDi>
    <basicUdiDi>B-06977846952685</basicUdiDi>
    <tradeName>Tumor Companion Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangxi CellGene Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055358</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E020400501</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T07:44:13.012Z</lastUpdated>
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    <udiDi>06977846952692</udiDi>
    <basicUdiDi>B-06977846952692</basicUdiDi>
    <tradeName>Tumor Companion Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangxi CellGene Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055358</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E020400502</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T07:44:12.578Z</lastUpdated>
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    <udiDi>06977846952708</udiDi>
    <basicUdiDi>B-06977846952708</basicUdiDi>
    <tradeName>Tumor Companion Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangxi CellGene Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055358</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E020400503</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T07:44:12.417Z</lastUpdated>
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    <udiDi>06977846952715</udiDi>
    <basicUdiDi>B-06977846952715</basicUdiDi>
    <tradeName>Tumor Companion Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangxi CellGene Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055358</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E020400504</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T07:44:12.145Z</lastUpdated>
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    <udiDi>06977846951756</udiDi>
    <basicUdiDi>B-06977846951756</basicUdiDi>
    <tradeName>Food Allergen Specific IgG Antibodies Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangxi CellGene Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055358</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E020700403</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T07:42:47.924Z</lastUpdated>
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    <udiDi>06977846951725</udiDi>
    <basicUdiDi>B-06977846951725</basicUdiDi>
    <tradeName>Food Allergen Specific IgG Antibodies Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangxi CellGene Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055358</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E020700404</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T07:42:47.708Z</lastUpdated>
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    <udiDi>06977846951688</udiDi>
    <basicUdiDi>B-06977846951688</basicUdiDi>
    <tradeName>Absolute Counting Tubes (Lyophilized Pellets)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangxi CellGene Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055358</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E020800101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T07:42:47.466Z</lastUpdated>
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    <udiDi>06977846951848</udiDi>
    <basicUdiDi>B-06977846951848</basicUdiDi>
    <tradeName>Absolute Counting Tubes (Lyophilized Pellets)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangxi CellGene Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055358</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E020800102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T07:42:09.870Z</lastUpdated>
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    <udiDi>06977846952487</udiDi>
    <basicUdiDi>B-06977846952487</basicUdiDi>
    <tradeName>TBNK Kit with Absolute Counting (Lyophilized Pellets)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangxi CellGene Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055358</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E021200201</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T07:42:09.685Z</lastUpdated>
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    <udiDi>06977846952500</udiDi>
    <basicUdiDi>B-06977846952500</basicUdiDi>
    <tradeName>TBNK Kit with Absolute Counting (Lyophilized Pellets)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangxi CellGene Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055358</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E021200203</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T07:41:44.455Z</lastUpdated>
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    <udiDi>06977846952517</udiDi>
    <basicUdiDi>B-06977846952517</basicUdiDi>
    <tradeName>TBNK Kit with Absolute Counting (Lyophilized Pellets)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangxi CellGene Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055358</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E021200204</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T07:41:18.656Z</lastUpdated>
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    <udiDi>06977846952524</udiDi>
    <basicUdiDi>B-06977846952524</basicUdiDi>
    <tradeName>TBNK Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangxi CellGene Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055358</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E021400101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T07:39:43.693Z</lastUpdated>
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    <udiDi>06977846952531</udiDi>
    <basicUdiDi>B-06977846952531</basicUdiDi>
    <tradeName>TBNK Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangxi CellGene Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055358</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E021400102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T07:39:22.476Z</lastUpdated>
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    <udiDi>06977846952548</udiDi>
    <basicUdiDi>B-06977846952548</basicUdiDi>
    <tradeName>TBNK Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangxi CellGene Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055358</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E021400103</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T07:39:22.310Z</lastUpdated>
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    <udiDi>06977846952555</udiDi>
    <basicUdiDi>B-06977846952555</basicUdiDi>
    <tradeName>TBNK Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangxi CellGene Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055358</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E021400104</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T07:39:22.088Z</lastUpdated>
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    <udiDi>06977846952418</udiDi>
    <basicUdiDi>B-06977846952418</basicUdiDi>
    <tradeName>PD-1 QuantPlus Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangxi CellGene Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055358</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E021500102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T07:28:32.259Z</lastUpdated>
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    <udiDi>06977846952432</udiDi>
    <basicUdiDi>B-06977846952432</basicUdiDi>
    <tradeName>PD-1 QuantPlus Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangxi CellGene Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055358</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E021500201</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T07:28:32.174Z</lastUpdated>
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