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    <manufacturerName>Shandong Bohong Gene Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025971</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <lastUpdated>2026-07-02T14:42:46.140Z</lastUpdated>
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    <deviceName>Palm Fluorescent PCR Analyzer</deviceName>
    <manufacturerName>Zhuhai Shineway Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027278</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <tradeName>Nucleic Acid Release Reagent</tradeName>
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    <deviceName>Real-time PCR Nucleic Acid Detection System</deviceName>
    <manufacturerName>Zhuhai Shineway Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027278</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <deviceName>Fully Automated PCR Detection System</deviceName>
    <manufacturerName>Zhuhai Shineway Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027278</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <basicUdiDi>697490060SWSI-0243</basicUdiDi>
    <tradeName>Hand-held Nucleic Acid Detection Analyzer</tradeName>
    <deviceName>Hand-held Nucleic Acid Detection Analyzer</deviceName>
    <manufacturerName>Zhuhai Shineway Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027278</manufacturerSrn>
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    <tradeName>Real-time PCR Nucleic Acid Detection System</tradeName>
    <deviceName>Real-time PCR Nucleic Acid Detection System</deviceName>
    <manufacturerName>Zhuhai Shineway Biotech Co.,Ltd</manufacturerName>
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    <tradeName>PCR Nucleic Acid Analyzer</tradeName>
    <deviceName>PCR Nucleic Acid Analyzer</deviceName>
    <manufacturerName>Zhuhai Shineway Biotech Co.,Ltd</manufacturerName>
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    <lastUpdated>2026-07-02T14:40:26.066Z</lastUpdated>
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    <deviceName>All-in-one Molecular Diagnosis System</deviceName>
    <manufacturerName>Xi'an Tianlong Science and Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001079</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <lastUpdated>2026-07-02T14:39:22.761Z</lastUpdated>
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    <deviceName>Real-Time PCR System</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:29:28.337Z</lastUpdated>
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    <deviceName>Real-Time PCR System</deviceName>
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    <deviceName>Real-Time PCR System</deviceName>
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    <deviceName>Automatic Nucleic Acid Detection and Analysis System</deviceName>
    <manufacturerName>Shanghai Rendu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018869</manufacturerSrn>
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    <lastUpdated>2026-07-02T14:23:09.351Z</lastUpdated>
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    <tradeName>Biocomma</tradeName>
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    <manufacturerName>Biocomma Limited</manufacturerName>
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    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <tradeName>Biocomma</tradeName>
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    <tradeName>Biocomma</tradeName>
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    <lastUpdated>2026-07-02T14:04:29.393Z</lastUpdated>
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