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    <manufacturerName>Hangzhou LongGene Scientific Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024510</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q160A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:31:56.126Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Hangzhou LongGene Scientific Instruments Co., Ltd.</manufacturerName>
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    <manufacturerName>Hangzhou LongGene Scientific Instruments Co., Ltd.</manufacturerName>
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    <manufacturerName>Igenesis(Shanghai)Co.,Ltd.</manufacturerName>
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    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:30:33.132Z</lastUpdated>
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    <udiDi>06975447581044</udiDi>
    <basicUdiDi>697544758GALAXYU9</basicUdiDi>
    <tradeName>Galaxy Lite</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Igenesis(Shanghai)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001552</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>06975447581068</udiDi>
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    <tradeName>Galaxy Neo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Igenesis(Shanghai)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001552</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Thermal Cycler&amp;Real-time PCR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Infitek Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040107</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:29:57.993Z</lastUpdated>
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    <tradeName>Real-time PCR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Infitek Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040107</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCR-Q96-6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:29:57.199Z</lastUpdated>
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    <udiDi>06975514360558</udiDi>
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    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bigfish Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027212</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFEX-24E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:29:26.134Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bigfish Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027212</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFEX-32E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:29:26.122Z</lastUpdated>
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    <manufacturerName>Hangzhou Bigfish Bio-tech Co., Ltd.</manufacturerName>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <manufacturerName>Hangzhou Bigfish Bio-tech Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <manufacturerName>Hangzhou Bigfish Bio-tech Co., Ltd.</manufacturerName>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:29:26.063Z</lastUpdated>
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    <tradeName>Sikun 1000</tradeName>
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    <manufacturerName>Sikun Life Science Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047921</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <emdnDescription>DNA SYNTHESIZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5074</reference>
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    <lastUpdated>2026-06-16T09:27:20.380Z</lastUpdated>
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    <manufacturerName>Sikun Life Science Co., Ltd.</manufacturerName>
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    <manufacturerName>Sikun Life Science Co., Ltd.</manufacturerName>
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    <emdnDescription>DNA SYNTHESIZERS</emdnDescription>
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    <tradeName>YJSeq 300 Dx Sequencing Kit</tradeName>
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    <manufacturerName>Shanghai YJMED BioTechnology Co., Ltd.</manufacturerName>
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    <manufacturerName>Shanghai YJMED BioTechnology Co., Ltd.</manufacturerName>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
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    <reference>FCM 300cycles</reference>
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