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    <deviceName>DNA/RNA Extraction/Purification Kit</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>
    <emdnCode>W0104080601</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED BACTERIA SPP / SSPP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFMP01R</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T14:29:00.139Z</lastUpdated>
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    <tradeName>Femoflor® 16</tradeName>
    <deviceName>Femoflor® 16 REAL-TIME PCR Detection Kit</deviceName>
    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
    <manufacturerSrn>RU-MF-000028223</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1-P801-S3/6EU</reference>
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    <tradeName>Sepsis pathogenic microorganism detection kit (digital PCR)</tradeName>
    <deviceName>Sepsis pathogenic microorganism detection kit (digital PCR)</deviceName>
    <manufacturerName>Suzhou Precigenome Ltd, Co;</manufacturerName>
    <manufacturerSrn>CN-MF-000024105</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080601</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED BACTERIA SPP / SSPP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.02.03.0007</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:11:16.500Z</lastUpdated>
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    <udiDi>06975514360138</udiDi>
    <basicUdiDi>697551436BFMP001NK</basicUdiDi>
    <tradeName>06975514360138</tradeName>
    <deviceName>DNA/RNA Extraction/Purification Kit</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>
    <emdnCode>W0104080601</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED BACTERIA SPP / SSPP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFMP02R1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:13:19.810Z</lastUpdated>
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    <udiDi>06975514360145</udiDi>
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    <tradeName>06975514360145</tradeName>
    <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>
    <emdnCode>W0104080601</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED BACTERIA SPP / SSPP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <deviceName></deviceName>
    <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 IDENTIFICATION - MANUAL / AUTOMATED BACTERIA SPP / SSPP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
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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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    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED BACTERIA SPP / SSPP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:29:26.394Z</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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    <riskClass>IVD Sınıf A</riskClass>
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    <emdnCode>W0104080601</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED BACTERIA SPP / SSPP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFMP08R1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:29:26.381Z</lastUpdated>
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    <udiDi>06975514360190</udiDi>
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    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bigfish Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027212</manufacturerSrn>
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    <emdnCode>W0104080601</emdnCode>
    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED BACTERIA SPP / SSPP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:29:26.370Z</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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    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED BACTERIA SPP / SSPP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:29:26.358Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bigfish Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027212</manufacturerSrn>
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    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED BACTERIA SPP / SSPP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:29:26.346Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bigfish Bio-tech Co., Ltd.</manufacturerName>
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    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED BACTERIA SPP / SSPP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:29:26.336Z</lastUpdated>
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    <manufacturerName>Hangzhou Bigfish Bio-tech Co., Ltd.</manufacturerName>
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    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED BACTERIA SPP / SSPP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <manufacturerName>Hangzhou Bigfish Bio-tech Co., Ltd.</manufacturerName>
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    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED BACTERIA SPP / SSPP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-16T09:29:26.315Z</lastUpdated>
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    <manufacturerName>Hangzhou Bigfish Bio-tech Co., Ltd.</manufacturerName>
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    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED BACTERIA SPP / SSPP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-16T09:29:26.305Z</lastUpdated>
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    <manufacturerName>Hangzhou Bigfish Bio-tech Co., Ltd.</manufacturerName>
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    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED BACTERIA SPP / SSPP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:29:26.293Z</lastUpdated>
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    <manufacturerName>Hangzhou Bigfish Bio-tech Co., Ltd.</manufacturerName>
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    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED BACTERIA SPP / SSPP</emdnDescription>
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    <manufacturerName>Hangzhou Bigfish Bio-tech Co., Ltd.</manufacturerName>
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    <emdnDescription>NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED BACTERIA SPP / SSPP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <manufacturerName>Hangzhou Bigfish Bio-tech Co., Ltd.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFMP14R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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