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    <tradeName>SARS-CoV-2 &amp; Influenza A/B &amp; RSV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)</tradeName>
    <deviceName>SARS-CoV-2 &amp; Influenza A/B &amp; RSV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070399</emdnCode>
    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-71-5</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:50:49.329Z</lastUpdated>
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    <basicUdiDi>B-06971348761318</basicUdiDi>
    <tradeName>SARS-CoV-2 &amp; Influenza A/B &amp; RSV Antigen Combo Test  Kit (Colloidal Gold Chromatographic Immunoassay)</tradeName>
    <deviceName>SARS-CoV-2 &amp; Influenza A/B &amp; RSV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <emdnDescription>MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER</emdnDescription>
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    <reference>MF-71-2</reference>
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    <lastUpdated>2026-07-06T09:50:36.065Z</lastUpdated>
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    <basicUdiDi>B-06971225938413</basicUdiDi>
    <tradeName>SARS-CoV-2 &amp; Influenza A/B &amp; RSV Antigen Kit (Colloidal Gold)</tradeName>
    <deviceName>SARS-CoV-2 &amp; Influenza A/B &amp; RSV Antigen Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CG127025</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:29:48.521Z</lastUpdated>
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    <basicUdiDi>B-06971225938406</basicUdiDi>
    <tradeName>SARS-CoV-2 &amp; Influenza A/B &amp; RSV Antigen Kit (Colloidal Gold)</tradeName>
    <deviceName>SARS-CoV-2 &amp; Influenza A/B &amp; RSV Antigen Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CG127001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:29:46.818Z</lastUpdated>
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    <udiDi>06971225937348</udiDi>
    <basicUdiDi>B-06971225937348</basicUdiDi>
    <tradeName>SARS-CoV2 &amp; Influenza A/B Antigen Kit (Colloidal Gold)</tradeName>
    <deviceName>SARS-CoV2 &amp; Influenza A/B Antigen Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CG125025</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:29:30.005Z</lastUpdated>
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    <basicUdiDi>B-06971225936426</basicUdiDi>
    <tradeName>SARS-CoV-2 &amp; Influenza A/B &amp; RSV Antigen Kit (Colloidal Gold)</tradeName>
    <deviceName>SARS-CoV-2 &amp; Influenza A/B &amp; RSV Antigen Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CG127005</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:28:50.742Z</lastUpdated>
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    <basicUdiDi>B-06971225936419</basicUdiDi>
    <tradeName>SARS-CoV-2 Antigen Kit (Colloidal Gold)  (for self-testing)</tradeName>
    <deviceName>SARS-CoV-2 Antigen Kit (Colloidal Gold)  (for self-testing)</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CG123003</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:28:49.148Z</lastUpdated>
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    <udiDi>06971225936211</udiDi>
    <basicUdiDi>B-06971225936211</basicUdiDi>
    <tradeName>SARS-CoV2 &amp; Influenza A/B Antigen Kit (Colloidal Gold)</tradeName>
    <deviceName>SARS-CoV2 &amp; Influenza A/B Antigen Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CG125001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:28:26.720Z</lastUpdated>
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    <udiDi>06971225931674</udiDi>
    <basicUdiDi>B-06971225931674</basicUdiDi>
    <tradeName>SARS-CoV-2 Antigen Kit (Colloidal Gold)  (for self-testing)</tradeName>
    <deviceName>SARS-CoV-2 Antigen Kit (Colloidal Gold)  (for self-testing)</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CG123025</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:24:14.284Z</lastUpdated>
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    <basicUdiDi>B-06971225931667</basicUdiDi>
    <tradeName>SARS-CoV-2 Antigen Kit (Colloidal Gold)  (for self-testing)</tradeName>
    <deviceName>SARS-CoV-2 Antigen Kit (Colloidal Gold)  (for self-testing)</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CG123005</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:24:09.392Z</lastUpdated>
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    <udiDi>06971225931650</udiDi>
    <basicUdiDi>B-06971225931650</basicUdiDi>
    <tradeName>SARS-CoV-2 Antigen Kit (Colloidal Gold)  (for self-testing)</tradeName>
    <deviceName>SARS-CoV-2 Antigen Kit (Colloidal Gold)  (for self-testing)</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CG123001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:24:08.577Z</lastUpdated>
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    <udiDi>06971225930271</udiDi>
    <basicUdiDi>B-06971225930271</basicUdiDi>
    <tradeName>SARS-CoV2 &amp; Influenza A/B Antigen Kit (Colloidal Gold)</tradeName>
    <deviceName>SARS-CoV2 &amp; Influenza A/B Antigen Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CG125005</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:21:00.264Z</lastUpdated>
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    <basicUdiDi>B-06971042228391</basicUdiDi>
    <tradeName>N7 Gene of Influenza Virus A Real Time RT-PCR Kit</tradeName>
    <deviceName>N7 Gene of Influenza Virus A Real Time RT-PCR Kit</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>IVDD</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RR-0323-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:01:06.002Z</lastUpdated>
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    <basicUdiDi>B-06971042228384</basicUdiDi>
    <tradeName>N3 Gene of Influenza Virus A Real Time RT-PCR Kit</tradeName>
    <deviceName>N3 Gene of Influenza Virus A Real Time RT-PCR Kit</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>IVDD</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RR-0322-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:01:04.427Z</lastUpdated>
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    <basicUdiDi>B-06971042228377</basicUdiDi>
    <tradeName>N2 Gene of Influenza Virus A Real Time RT-PCR Kit</tradeName>
    <deviceName>N2 Gene of Influenza Virus A Real Time RT-PCR Kit</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>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RR-0321-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:01:03.592Z</lastUpdated>
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    <basicUdiDi>B-06971042228360</basicUdiDi>
    <tradeName>N1 Gene of Influenza Virus A Real Time RT-PCR Kit</tradeName>
    <deviceName>N1 Gene of Influenza Virus A Real Time RT-PCR Kit</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>IVDD</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RR-0320-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:01:01.987Z</lastUpdated>
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    <basicUdiDi>B-06971042228353</basicUdiDi>
    <tradeName>HRV/RSV/HMPV Multiplex Real Time RT-PCR Kit</tradeName>
    <deviceName>HRV/RSV/HMPV Multiplex Real Time RT-PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RR-0312-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:00:59.618Z</lastUpdated>
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    <basicUdiDi>B-06971042228308</basicUdiDi>
    <tradeName>Influenza  Virus A H1&amp;H3  Real Time RT-PCR Kit</tradeName>
    <deviceName>Influenza  Virus A H1&amp;H3  Real Time RT-PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>RR-0235-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:00:53.186Z</lastUpdated>
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    <basicUdiDi>B-06971042228315</basicUdiDi>
    <tradeName>Influenza Virus B Typing 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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>RR-0263-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:00:51.895Z</lastUpdated>
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    <basicUdiDi>B-06971042228292</basicUdiDi>
    <tradeName>Influenza Virus A,B&amp;C Real Time RT-PCR Kit</tradeName>
    <deviceName>Influenza Virus A,B&amp;C Real Time RT-PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
    <emdnCode>W0105070304</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RR-0223-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:00:37.936Z</lastUpdated>
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