D-84295775237XEGW B-84295775237XEGW Real SARS-CoV-2/Flu/RSV Real SARS-CoV-2/Flu/RSV OPERON, S.A. ES-MF-000004790 IVD Genel IVDD W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS Piyasada 5.237.XXX.88.ZZZ Spain 2026-07-12T07:08:33.339Z D-81649002AFR01EJB5 B-81649002AFR01EJB5 D-81649002AFR01EJB5 Influenza A/ B and Respiratory Syncytial Virus Detection Kit (Fluorescence PCR) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS Piyasada AFR01-AHG48E; AFR01-AHG96E; AFR01D-AHG48E; AFR01D-AHG96E Germany 2026-07-12T06:59:58.322Z D-81649002ACOV03DXMV B-81649002ACOV03DXMV D-81649002ACOV03DXMV SARS-CoV-2 Detection Kit (Fluorescence RT-PCR) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS Piyasada ACOV03-AHG48E; ACOV03-AHG96E; ACOV03D-AHG48E; ACOV03D-AHG96E Germany 2026-07-12T06:59:29.481Z D-81649002ACOV03DEUWD B-81649002ACOV03DEUWD D-81649002ACOV03DEUWD SARS-CoV-2 Fluorescence PCR Kit (Lyophilized) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS Piyasada ACOV03D-AHG48E; ACOV03D-AHG96E Germany 2026-07-12T06:59:28.687Z D-81649002ACOV01DTMB B-81649002ACOV01DTMB D-81649002ACOV01DTMB SARS-CoV-2 Detection Kit (Direct Fluorescence PCR） Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS Piyasada ACOV01-AHG48E; ACOV01-AHG96E Germany 2026-07-12T06:59:24.884Z D-81649002ACAB04D5RDF B-81649002ACAB04D5RDF D-81649002ACAB04D5RDF SARS-CoV-2 & Influenza A/B Detection Kit (Fluorescence PCR) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS Piyasada ACAB04D-BHG48E Germany 2026-07-12T06:59:24.314Z D-81649002ACAB017M77 B-81649002ACAB017M77 D-81649002ACAB017M77 SARS-CoV-2 & Influenza A/B Detection Kit (Direct Fluorescence PCR) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS Piyasada ACAB01-AHG48E; ACAB01-AHG96E Germany 2026-07-12T06:59:23.075Z D-81649002101A0227EYDUX7 B-81649002101A0227EYDUX7 D-81649002101A0227EYDUX7 SARS-CoV-2 Detection Kit (Fluorescence PCR) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS Piyasada 101A0227EY Germany 2026-07-12T06:59:18.273Z 08885019710827 B-08885019710827 08885019710827 abTES™ Flu/COVID-19 qPCR I Kit (100 Reactions) AITbiotech Pte Ltd SG-MF-000003510 RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202 IVD Genel IVDD W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS Piyasada 300144 Spain 2026-07-10T14:20:49.892Z 08885019710810 B-08885019710810 08885019710810 abTES™ Flu/COVID-19 qPCR I Kit (50 Reactions) AITbiotech Pte Ltd SG-MF-000003510 RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202 IVD Genel IVDD W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS Piyasada 300143 Spain 2026-07-10T14:20:48.292Z 08885019710766 B-08885019710766 08885019710766 abTES™ FLU/RSV qPCR I Kit (100 Reactions) AITbiotech Pte Ltd SG-MF-000003510 RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202 IVD Genel IVDD W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS Piyasada 300268 Spain 2026-07-10T14:20:41.893Z 08885019710704 B-08885019710704 08885019710704 abTES™ FLU/RSV qPCR I Kit (50 Reactions) AITbiotech Pte Ltd SG-MF-000003510 RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202 IVD Genel IVDD W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS Piyasada 300267 Spain 2026-07-10T14:20:17.884Z 08885013953848 B-08885013953848 ViroKey Flu A/B & RSV RT-PCR Extension Kit ViroKey Flu A/B & RSV RT-PCR Extension Kit Vela Operations Singapore Pte. Ltd. SG-MF-000025684 Vela Diagnostics Germany GmbH DE-AR-000016088 IVD Genel IVDD W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS Piyasada 301074 Germany 2026-07-10T14:17:59.604Z 08809240103043 B-08809240103043 Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay Seegene, Inc. KR-MF-000022275 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Genel IVDD W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS Piyasada RV10349Z Germany 2026-07-10T09:45:24.281Z 08809240103036 B-08809240103036 Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay Seegene, Inc. KR-MF-000022275 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Genel IVDD W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS Piyasada RV10259X Germany 2026-07-10T09:45:23.481Z 08800204300232 B-08800204300232 08800204300232 RADI FAST Flu-SC2-RSV Detection Kit KH Medical Co., Ltd. KR-MF-000017883 Medical Technology Promedt Consulting GmbH DE-AR-000000085 IVD Genel IVDD W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS Piyasada RV013F Germany 2026-07-10T05:14:42.349Z 08800056369333 B-08800056369333 PowerChek™ SARS-CoV-2, Influenza A&B Multiplex Real-time PCR Kit PowerChek™ SARS-CoV-2, Influenza A&B Multiplex Real-time PCR Kit KogeneBiotech Co., Ltd. KR-MF-000045858 Obelis s.a. BE-AR-000000106 IVD Genel IVDD W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS Piyasada IR6903N Czechia 2026-07-09T22:32:54.802Z 08800056369302 B-08800056369302 PowerChek™ SARS-CoV-2, Influenza A&B, RSV Multiplex Real-time PCR Kit II PowerChek™ SARS-CoV-2, Influenza A&B, RSV Multiplex Real-time PCR Kit II KogeneBiotech Co., Ltd. KR-MF-000045858 Obelis s.a. BE-AR-000000106 IVD Genel IVDD W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS Piyasada R6905Q Belgium 2026-07-09T22:32:53.202Z 08800056369296 B-08800056369296 PowerChek™ SARS-CoV-2, Influenza A&B, RSV Multiplex Real-time PCR Kit II PowerChek™ SARS-CoV-2, Influenza A&B, RSV Multiplex Real-time PCR Kit II KogeneBiotech Co., Ltd. KR-MF-000045858 Obelis s.a. BE-AR-000000106 IVD Genel IVDD W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS Piyasada R6905N Czechia 2026-07-09T22:32:52.403Z 08800056369234 B-08800056369234 PowerChek™ SARS-CoV-2, Influenza A&B Multiplex Real-time PCR Kit PowerChek™ SARS-CoV-2, Influenza A&B Multiplex Real-time PCR Kit KogeneBiotech Co., Ltd. KR-MF-000045858 Obelis s.a. BE-AR-000000106 IVD Genel IVDD W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS Piyasada IR6903Q Czechia 2026-07-09T22:32:50.803Z