08437016942338 B-08437016942338 Adellgene® Myotonic Dystrophy Screening 16 tests Adellgene® Myotonic Dystrophy Screening 16 tests Blackhills Diagnostic Resources S.L.U. ES-MF-000001091 IVD Genel IVDD W0106010199 MONOGENETIC DISORDERS TESTS - OTHER Piyasada AD-MD-16 Spain 2026-07-07T21:53:28.771Z 08437016942307 B-08437016942307 Adellgene® Fragile X Screening 48 tests Adellgene® Fragile X Screening 48 tests Blackhills Diagnostic Resources S.L.U. ES-MF-000001091 IVD Genel IVDD W0106010104 FRAGILE X SYNDROME Piyasada AD-FX-48 Spain 2026-07-07T21:53:27.997Z 08437016942291 B-08437016942291 Adellgene® Fragile X Screening 16 tests Adellgene® Fragile X Screening 16 tests Blackhills Diagnostic Resources S.L.U. ES-MF-000001091 IVD Genel IVDD W0106010104 FRAGILE X SYNDROME Piyasada AD-FX-16 Spain 2026-07-07T21:53:23.979Z 08436589881853 B-08436589881853 Inherited CardioKitDx Inherited CardioKitDx Health in Code, S.L. ES-MF-000054848 IVD Genel IVDD W0106010199 MONOGENETIC DISORDERS TESTS - OTHER Piyasada IMG-390 Spain 2026-07-07T21:50:54.180Z 08057723370615 B-08057723370615 08057723370615 SMART SNP MTHFR 1298 Positive Control BIOCLARMA S.R.L. IT-MF-000030384 IVD Genel IVDD W0106010199 MONOGENETIC DISORDERS TESTS - OTHER Piyasada SNPD-032 CTRL Italy 2026-07-07T18:37:31.848Z 08057723370608 B-08057723370608 08057723370608 SMART SNP Coagulation Factors POSITIVE CONTROL BIOCLARMA S.R.L. IT-MF-000030384 IVD Genel IVDD W0106010199 MONOGENETIC DISORDERS TESTS - OTHER Piyasada SNPD-CF CTRL Italy 2026-07-07T18:37:31.032Z 08057723370110 B-08057723370110 08057723370110 SMART SNP FII FVL Direct Kit BIOCLARMA S.R.L. IT-MF-000030384 IVD Genel IVDD W0106010115 COMBINED FACTOR II / FACTOR V LEIDEN Piyasada SNPD-034 Italy 2026-07-07T18:35:54.927Z 08057723370103 B-08057723370103 08057723370103 SMART SNP MTHFR 677 Direct Kit BIOCLARMA S.R.L. IT-MF-000030384 IVD Genel IVDD W0106010199 MONOGENETIC DISORDERS TESTS - OTHER Piyasada SNPD-033 Italy 2026-07-07T18:35:54.255Z 08057723370097 B-08057723370097 08057723370097 SMART SNP MTHFR 1298 Direct Kit BIOCLARMA S.R.L. IT-MF-000030384 IVD Genel IVDD W0106010199 MONOGENETIC DISORDERS TESTS - OTHER Piyasada SNPD-032 Italy 2026-07-07T18:35:53.309Z 08057723370080 B-08057723370080 08057723370080 SMART SNP FVL Direct Kit BIOCLARMA S.R.L. IT-MF-000030384 IVD Genel IVDD W0106010103 FACTOR V LEIDEN Piyasada SNPD-030 Italy 2026-07-07T18:35:48.512Z 08057723370073 B-08057723370073 08057723370073 SMART SNP FII Direct Kit BIOCLARMA S.R.L. IT-MF-000030384 IVD Genel IVDD W0106010114 PROTHROMBIN MUTATION Piyasada SNPD-029 Italy 2026-07-07T18:35:47.711Z 08720211480270 872021148P0155H SALSA MLPA Probemix P015 MECP2 MRC Holland B.V. NL-MF-000000437 IVD Sınıf C IVDR 2017/746 W0106010199 MONOGENETIC DISORDERS TESTS - OTHER Piyasada P015-100R 2026-07-07T12:44:23.783Z 08033629920321 B-08033629920321 08033629920321 Cystic Fibrosis Nuclear Laser Medicine srl IT-MF-000025709 IVD Genel IVDD W0106010101 CYSTIC FIBROSIS Piyasada AC023/25 Italy 2026-07-07T09:14:16.242Z 07350040631614 B-07350040631614 Devyser Thalassemia Devyser Thalassemia Devyser AB SE-MF-000001699 IVD Genel IVDD W0106010111 THALASSAEMIA Piyasada 8-A106-96 Sweden 2026-07-07T01:13:58.041Z 07350040631607 B-07350040631607 Devyser Thalassemia Devyser Thalassemia Devyser AB SE-MF-000001699 IVD Genel IVDD W0106010111 THALASSAEMIA Piyasada 8-A106-48 Sweden 2026-07-07T01:13:41.975Z 07350040631591 B-07350040631591 Devyser Thalassemia Devyser Thalassemia Devyser AB SE-MF-000001699 IVD Genel IVDD W0106010111 THALASSAEMIA Piyasada 8-A106-24 Sweden 2026-07-07T01:13:39.574Z 07350040630648 B-07350040630648 Devyser CFTR 68 Devyser CFTR 68 Devyser AB SE-MF-000001699 IVD Genel IVDD W0106010101 CYSTIC FIBROSIS Piyasada 8-A045 Sweden 2026-07-07T01:13:20.361Z 07350040630624 B-07350040630624 Devyser CFTR 68 Devyser CFTR 68 Devyser AB SE-MF-000001699 IVD Genel IVDD W0106010101 CYSTIC FIBROSIS Piyasada 8-A045-8 Sweden 2026-07-07T01:13:19.561Z 07350040630617 B-07350040630617 Devyser CFTR 68 Devyser CFTR 68 Devyser AB SE-MF-000001699 IVD Genel IVDD W0106010101 CYSTIC FIBROSIS Piyasada 8-A045-24 Sweden 2026-07-07T01:13:17.977Z 07350040630488 B-07350040630488 Devyser Thrombophilia Devyser Thrombophilia Devyser AB SE-MF-000001699 IVD Genel IVDD W0106010116 OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5) Piyasada 8-A035 Sweden 2026-07-07T01:13:02.752Z