D-81649002AEGFR01D6SQ B-81649002AEGFR01D6SQ D-81649002AEGFR01D6SQ EGFR Gene Mutation Detection Kit（Fluorescence PCR） Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER Piyasada AEGFR01-AHG24E Germany 2026-07-12T06:59:37.478Z D-81649002AEBV01DAZQ6 B-81649002AEBV01DAZQ6 D-81649002AEBV01DAZQ6 Epstein-Barr Virus Fluorescence PCR Kit (Lyophilized) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105040403 EBV - NA REAGENTS Piyasada AEBV01D-AHG48E Germany 2026-07-12T06:59:36.683Z D-81649002AEBV01BNGJ B-81649002AEBV01BNGJ D-81649002AEBV01BNGJ Epstein-Barr Virus Detection Kit (Fluorescence PCR) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105040403 EBV - NA REAGENTS Piyasada AEBV01-AHG48E; AEBV01D-AHG48E Germany 2026-07-12T06:59:35.876Z D-81649002ADZCOM01D7667 B-81649002ADZCOM01D7667 D-81649002ADZCOM01D7667 DENV/ZIKV/CHIKV/OROV/MAYV Fluorescence PCR Kit (Lyophilized) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105900102 REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS Piyasada ADZCOM01D-AHG48E Germany 2026-07-12T06:59:35.078Z D-81649002ADV01EQC5 B-81649002ADV01EQC5 D-81649002ADV01EQC5 Dengue Virus Detection Kit (Fluorescence PCR) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105040511 DENGUE VIRUS - NA REAGENTS Piyasada ADV01-AHG48E; ADV01-AHG96E; ADV01D-AHG48E; ADV01D-AHG96E Germany 2026-07-12T06:59:31.079Z D-81649002ADV01DB5CX B-81649002ADV01DB5CX D-81649002ADV01DB5CX Dengue Virus Fluorescence PCR Kit (Lyophilized) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105040511 DENGUE VIRUS - NA REAGENTS Piyasada ADV01D-AHG48E; ADV01D-AHG96E Germany 2026-07-12T06:59:30.276Z 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-81649002ABPTS02JB59 B-81649002ABPTS02JB59 D-81649002ABPTS02JB59 Bordetella Pertussis Detection Kit (Fluorescence PCR) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105011607 BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS Piyasada ABPTS02-AHG48E/ ABPTS02-AHG96E Germany 2026-07-12T06:59:22.276Z 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 00810173655187 81649002Mplex-M100RS 00810173655187 Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Sınıf A UNKNOWN W02020499 FLOW CYTOMETRY INSTRUMENTS - OTHER Piyasada M-FLA-202-01 2026-07-08T06:50:08.570Z 00816490028482 B-00816490028482 HCV Hepatitis C Virus Rapid Test (Serum/Plasma)(Cassette) HCV Hepatitis C Virus Rapid Test (Serum/Plasma)(Cassette) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Ek II Liste A IVDD W0105090202 HCV ANTIBODY -RT & POC Piyasada GCHCV-302a Germany 2026-07-04T18:39:51.786Z 00816490028475 B-00816490028475 HCV Hepatitis C Virus Rapid Test (Serum/Plasma)(Cassette) HCV Hepatitis C Virus Rapid Test (Whole blood/Serum/Plasma)(Cassette) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Ek II Liste A IVDD W0105090202 HCV ANTIBODY -RT & POC Piyasada GCHCV-402a Germany 2026-07-04T18:39:50.197Z 00816490028444 81649002OG-G3008A Hand-Held Immunofluorescence Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Sınıf A IVDR 2017/746 W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER Piyasada OG-G300 Germany 2026-07-03T09:44:18.279Z 00816490028437 81649002OG-G20085 Immunofluorescence Analyzer Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Sınıf A IVDR 2017/746 W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER Piyasada OG-G200 Germany 2026-07-03T09:44:14.283Z 00816490028420 81649002OG-H10087 Mini Immunofluorescence Analyzer Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Sınıf A IVDR 2017/746 W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER Piyasada OG-H100 Germany 2026-07-03T09:44:13.500Z 00816490028192 81649002OG-H1808X Immunofluorescence Analyzer Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Sınıf A IVDR 2017/746 W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER Piyasada OG-H180 Germany 2026-07-03T09:44:12.701Z