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    <tradeName>Blood Genomic DNA Isolation Kit (Preloaded for Auto-Extraction)</tradeName>
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    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription></emdnDescription>
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    <reference>ME-0042</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:55:10.430Z</lastUpdated>
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    <basicUdiDi>697104222010003EM</basicUdiDi>
    <tradeName>Blood Genomic DNA Isolation Kit (Preloaded for Auto-Extraction)</tradeName>
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    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription></emdnDescription>
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    <basicUdiDi>697104222010008EX</basicUdiDi>
    <tradeName>Viral RNA Extraction Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
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    <emdnDescription></emdnDescription>
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    <tradeName>Viral RNA Extraction Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <basicUdiDi>697104222010007EV</basicUdiDi>
    <tradeName>Viral RNA Extraction Kit (for Auto-Extraction)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-0092-96</reference>
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    <lastUpdated>2026-06-16T10:55:10.334Z</lastUpdated>
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    <basicUdiDi>697104222010007EV</basicUdiDi>
    <tradeName>Viral RNA Extraction Kit (for Auto-Extraction)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-0092-384</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <basicUdiDi>697104222010009EZ</basicUdiDi>
    <tradeName>Viral Transport Medium</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PR-0028-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:55:10.308Z</lastUpdated>
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    <tradeName>Viral RNA Extraction Kit (Preloaded for Auto-Extraction)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-0093-60</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <basicUdiDi>697104222010010EJ</basicUdiDi>
    <tradeName>Viral RNA Extraction Kit (Preloaded for Auto-Extraction)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-0093-240</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:54:58.311Z</lastUpdated>
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    <basicUdiDi>697104222010012EN</basicUdiDi>
    <tradeName>Viral DNA/RNA Isolation Kit (for Auto-Extraction)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-0096-500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:54:58.292Z</lastUpdated>
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    <basicUdiDi>697104222010012EN</basicUdiDi>
    <tradeName>Viral DNA/RNA Isolation Kit (for Auto-Extraction)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-0096-2000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:54:58.269Z</lastUpdated>
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    <basicUdiDi>697104222010012EN</basicUdiDi>
    <tradeName>Viral DNA/RNA Isolation Kit (for Auto-Extraction)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-0096-10000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:54:58.250Z</lastUpdated>
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    <basicUdiDi>B-06971042228292</basicUdiDi>
    <tradeName>Influenza Virus A,B&amp;C Real Time RT-PCR Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RR-0223-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:54:58.231Z</lastUpdated>
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    <basicUdiDi>B-06971042228308</basicUdiDi>
    <tradeName>Influenza  Virus A H1&amp;H3  Real Time RT-PCR Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RR-0235-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:54:58.222Z</lastUpdated>
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    <basicUdiDi>B-06971042228315</basicUdiDi>
    <tradeName>Influenza Virus B Typing Real Time RT-PCR Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>06971042228322</udiDi>
    <basicUdiDi>B-06971042228322</basicUdiDi>
    <tradeName>Human Rhinovirus (HRV) Real Time RT-PCR Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
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    <tradeName>MERS-CoV Real Time RT-PCR Kit</tradeName>
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    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RR-0308-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:54:58.196Z</lastUpdated>
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    <tradeName>Human Infections with Avian Influenza A Virus (H7N9) RNA Real Time RT-PCR Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
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    <placedOnMarketCountry></placedOnMarketCountry>
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    <tradeName>HRV/RSV/HMPV Multiplex Real Time RT-PCR Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RR-0312-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>06971042228360</udiDi>
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    <tradeName>N1 Gene of Influenza Virus A Real Time RT-PCR Kit</tradeName>
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    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RR-0320-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:54:58.169Z</lastUpdated>
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