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 00810173657006 B-00810173657006 Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method) Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0106010199 MONOGENETIC DISORDERS TESTS - OTHER Piyasada N7001D Ireland 2026-07-04T16:03:54.317Z 00810173656993 B-00810173656993 Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method) Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0106010199 MONOGENETIC DISORDERS TESTS - OTHER Piyasada N7001C Ireland 2026-07-04T16:03:53.514Z 00810173656986 B-00810173656986 Nucleic Acid Detection Kit for Respiratory Tract Infection Pathogens (8 Types)(Flowcytometry Fluorescence Hybridization Method) Nucleic Acid Detection Kit for Respiratory Tract Infection Pathogens (8 Types)(Flowcytometry Fluorescence Hybridization Method) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105070503 RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS Piyasada 2RYT8A01 Ireland 2026-07-04T16:03:52.716Z 00810173656979 B-00810173656979 Nucleic Acid Detection Kit for Reproductive Tract Infection Pathogens (9 Types)(Flowcytometry Fluorescence Hybridization Method) Nucleic Acid Detection Kit for Reproductive Tract Infection Pathogens (9 Types)(Flowcytometry Fluorescence Hybridization Method) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS Piyasada 2RET9A01 Ireland 2026-07-04T16:03:51.919Z 00810173656962 B-00810173656962 Quantitative Analysis Kit for Four Inflammatory Markers (Flowcytometry Fluorescence Method) Quantitative Analysis Kit for Four Inflammatory Markers (Flowcytometry Fluorescence Method) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W01021499 MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER Piyasada 1IF4B01 Ireland 2026-07-04T16:03:47.909Z 00810173656955 B-00810173656955 Quantitative Analysis Kit for Six Cytokines (Flowcytometry Fluorescence Method) Quantitative Analysis Kit for Six Cytokines (Flowcytometry Fluorescence Method) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W01030699 LYMPHOKINES /IMMUNMODULATORS - OTHER Piyasada 1CK6B01 Ireland 2026-07-04T16:03:47.191Z 00810173656948 B-00810173656948 Nucleic Acid Genotyping Kit for Human Papillomavirus 29 types(Flowcytometry Fluorescence Hybridization Method) Nucleic Acid Genotyping Kit for Human Papillomavirus 29 types(Flowcytometry Fluorescence Hybridization Method) Healgen Scientific Limited Liability Company US-MF-000018839 Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001 IVD Genel IVDD W0105041005 OTHER HPV - NA REAGENTS Piyasada 2HPV29A01 Ireland 2026-07-04T16:03:46.317Z 00810173656931 B-00810173656931 Nucleic Acid Genotyping Kit for Human Papillomavirus 18 types (Flowcytometry Fluorescence Hybridization Method) Nucleic Acid Genotyping Kit for Human Papillomavirus 18 types (Flowcytometry Fluorescence Hybridization Method) Healgen Scientific Limited Liability Company US-MF-000018839 Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001 IVD Genel IVDD W0105041003 PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS Piyasada 2HPV18A01 Ireland 2026-07-04T16:03:45.517Z 00810173656924 B-00810173656924 Quantitative Analysis Kit for Alpha-fetoprotein and Carcino-embryonic antigen (Flowcytometry Fluorescence Method) Quantitative Analysis Kit for Alpha-fetoprotein and Carcino-embryonic antigen (Flowcytometry Fluorescence Method) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W01021499 MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER Piyasada 1TM2B01 Ireland 2026-07-04T16:03:41.507Z 00810173656917 B-00810173656917 Quantitative Analysis Kit for Pepsinogen I, Pepsinogen II and Gastrin-17(Flowcytometry Fluorescence Method) Quantitative Analysis Kit for Pepsinogen I, Pepsinogen II and Gastrin-17(Flowcytometry Fluorescence Method) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W01021499 MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER Piyasada 1GF3B01 Ireland 2026-07-04T16:03:40.710Z 00810173656900 B-00810173656900 Analysis Kit for Fifteen Autoantibodies Spectrum (Flowcytometry Fluorescence Method) Analysis Kit for Fifteen Autoantibodies Spectrum (Flowcytometry Fluorescence Method) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W01021499 MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER Piyasada 1AA15B01 Ireland 2026-07-04T16:03:39.905Z 00810173656894 B-00810173656894 Quantitative Analysis Kit for Six Tumor Markers (Flowcytometry Fluorescence Method) Quantitative Analysis Kit for Six Tumor Markers (Flowcytometry Fluorescence Method) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W01021499 MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER Piyasada 1TM6B01 Ireland 2026-07-04T16:03:39.111Z 00810173656887 B-00810173656887 Quantitative Analysis Kit for Seven Tumor Markers (Flowcytometry Fluorescence Method) Quantitative Analysis Kit for Seven Tumor Markers (Flowcytometry Fluorescence Method) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W01021499 MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER Piyasada 1TM7B01 Ireland 2026-07-04T16:03:23.916Z 00810173656870 B-00810173656870 Quantitative Analysis Kit for Three Tumor Markers (Flowcytometry Fluorescence Method) Quantitative Analysis Kit for Three Tumor Markers (Flowcytometry Fluorescence Method) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W01021499 MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER Piyasada 1TM3B01 Ireland 2026-07-04T16:03:23.051Z 00810173656863 B-00810173656863 In vitro Diagnostic Kit for Myoglobin (Chemiluminescence Assay) In vitro Diagnostic Kit for Myoglobin (Chemiluminescence Assay) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W01021304 MYOGLOBIN Piyasada 1MYOB02 Ireland 2026-07-04T16:03:19.043Z 00810173656856 B-00810173656856 In vitro Diagnostic Kit for Myoglobin (Chemiluminescence Assay) In vitro Diagnostic Kit for Myoglobin (Chemiluminescence Assay) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W01021304 MYOGLOBIN Piyasada 1MYOB01 Ireland 2026-07-04T16:03:18.245Z 00810173656849 B-00810173656849 In vitro Diagnostic Kit for High sensitivity Troponin T (Chemiluminescence Assay) In vitro Diagnostic Kit for High sensitivity Troponin T (Chemiluminescence Assay) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W01021306 TROPONIN I/T Piyasada 1CTNTB02 Ireland 2026-07-04T16:03:17.472Z 00810173656832 B-00810173656832 In vitro Diagnostic Kit for High sensitivity Troponin T (Chemiluminescence Assay) In vitro Diagnostic Kit for High sensitivity Troponin T (Chemiluminescence Assay) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W01021306 TROPONIN I/T Piyasada 1CTNTB01 Ireland 2026-07-04T16:03:16.644Z