05060456180300 506045618DSXFQ DSX Automated ELISA with 4 incubators and sample ID Dynex Technologies Inc US-MF-000014753 Acorn Regulatory Consultancy Services Ltd IE-AR-000000592 IVD Sınıf A UNKNOWN W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) Piyasada 65500 Spain 2026-07-19T15:28:37.523Z 05060456180317 506045618DS2DE DS2 without Barcode Scanner Dynex Technologies Inc US-MF-000014753 Acorn Regulatory Consultancy Services Ltd IE-AR-000000592 IVD Sınıf A UNKNOWN W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) Piyasada 62000 Netherlands 2026-07-19T15:28:37.499Z 05060456180539 506045618AGILITYBB AGILITY SOFTWARE Dynex Technologies Inc US-MF-000014753 Acorn Regulatory Consultancy Services Ltd IE-AR-000000592 IVD Sınıf A UNKNOWN W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) Piyasada 67800 Germany 2026-07-19T15:28:37.474Z 05060456180546 506045618DSXFQ Revelation DSX Software Dynex Technologies Inc US-MF-000014753 Acorn Regulatory Consultancy Services Ltd IE-AR-000000592 IVD Sınıf A UNKNOWN W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) Piyasada 65078 Spain 2026-07-19T15:28:37.459Z 05060456180614 506045618DS2DE DEEP WELL STRIPS Dynex Technologies Inc US-MF-000014753 Acorn Regulatory Consultancy Services Ltd IE-AR-000000592 IVD Sınıf A UNKNOWN W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) Piyasada 62910 Netherlands 2026-07-19T15:28:37.436Z 05060456180690 506045618DS2DE DS Matrix Software Dynex Technologies Inc US-MF-000014753 Acorn Regulatory Consultancy Services Ltd IE-AR-000000592 IVD Sınıf A UNKNOWN W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) Piyasada 62800 Netherlands 2026-07-19T15:28:37.411Z 05060456182434 506045618AGILITYBB AGILITY AI Dynex Technologies Inc US-MF-000014753 Acorn Regulatory Consultancy Services Ltd IE-AR-000000592 IVD Sınıf A UNKNOWN W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) Piyasada 67000AI Germany 2026-07-19T15:28:37.376Z 06954417600329 695441761107R832 Automatic Chemiluminescence Immunoassay Analyzer Automatic Chemiluminescence Immunoassay Analyzer Shanghai Medconn Medical Technology Co.,Ltd. CN-MF-000038658 JOYSUN GROUP S.L.U ES-AR-000043666 IVD Sınıf A IVDR 2017/746 W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) Piyasada NA Netherlands 2026-07-17T20:48:36.905Z 00630414655598 0405686900856W6 BN II System IVDR_27_MAR EB_A_INST_BNII Siemens Healthcare Diagnostics Products GmbH DE-MF-000005039 IVD Sınıf A IVDR 2017/746 W0201020204 NEPHELOMETERS Piyasada 11539176 Germany 2026-07-17T20:43:19.830Z 05061109831280 5060599400002PNT Fluorescence Immunoassay Analyzer Rapid Labs Ltd GB-MF-000026335 VidaQuick Biotech S.L. ES-AR-000048138 IVD Sınıf A UNKNOWN W0201020201 IMMUNOCHEMISTRY READERS Piyasada RL-FA-3B 2026-07-17T19:43:31.229Z 05061109831594 5060599400002PNT Fluorescence Immunoassay Analyzer Rapid Labs Ltd GB-MF-000026335 VidaQuick Biotech S.L. 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CN-MF-000038658 JOYSUN GROUP S.L.U ES-AR-000043666 IVD Sınıf A IVDR 2017/746 W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) Piyasada NA Netherlands 2026-07-17T04:09:26.360Z D-69717712029529U B-69717712029529U LYSUN Influenza A+B/ COVID-19/ RSV/HMPV Antigen Rapid Test Device Hangzhou Lysun Biotechnology Co., Ltd CN-MF-000010254 RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202 IVD Genel IVDD W02010299 IMMUNOCHEMISTRY INSTRUMENTS - OTHER Piyasada FCRH-S25（1PCS） Spain 2026-07-17T01:00:42.628Z D-69717712025949Q B-69717712025949Q LYSUN Influenza A+B/ COVID-19/ RSV/ADV/HMPV Antigen Rapid Test Hangzhou Lysun Biotechnology Co., Ltd CN-MF-000010254 RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202 IVD Genel IVDD W02010299 IMMUNOCHEMISTRY INSTRUMENTS - OTHER Piyasada FCRAH-S26（1PCS） Spain 2026-07-17T01:00:38.654Z D-69717712023899M B-69717712023899M LYSUN COVID-19 Antigen Rapid Test Device(Colloidal Gold) Hangzhou Lysun Biotechnology Co., Ltd CN-MF-000010254 RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202 IVD Genel IVDD W02010299 IMMUNOCHEMISTRY INSTRUMENTS - OTHER Piyasada COV-201（1PCS） Spain 2026-07-17T01:00:37.129Z D-6971771201979A9 B-6971771201979A9 LYSUN SARS-CoV-2 & Flu A/B Rapid Antigen Test Hangzhou Lysun Biotechnology Co., Ltd CN-MF-000010254 RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202 IVD Genel IVDD W02010299 IMMUNOCHEMISTRY INSTRUMENTS - OTHER Piyasada FCR-S23（1PCS） Spain 2026-07-17T00:59:12.064Z 6971771200859 B-6971771200859 Influenza A+B/COVID-19/ RSV Antigen Rapid Test Hangzhou Lysun Biotechnology Co., Ltd CN-MF-000010254 RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202 IVD Genel IVDD W02010299 IMMUNOCHEMISTRY INSTRUMENTS - OTHER Piyasada Influenza A+B/ COVID-19/ RSV Antigen Rapid Test Lithuania 2026-07-17T00:50:51.292Z 08806133090633 880613309063DS EZ POC System check cartridge EZ POC System check cartridge Boditech Med Inc. KR-MF-000011028 Obelis s.a. BE-AR-000000106 IVD Sınıf A IVDR 2017/746 W0201020180 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES Piyasada FPCC154 Austria 2026-07-16T09:44:39.737Z 08806133081389 880613308138DR ez-Tracker System check cartridge ez-Tracker System check cartridge Boditech Med Inc. KR-MF-000011028 Obelis s.a. BE-AR-000000106 IVD Sınıf A IVDR 2017/746 W0201020180 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES Piyasada ET001-SC France 2026-07-16T09:44:38.142Z