06959094210755 B-06959094210755 06959094210755 AmoyDx® KRAS Mutation Detection Kit Amoy Diagnostics Co., LTD. CN-MF-000021843 QbD RepS BV BE-AR-000000040 IVD Genel IVDD W01060202 K-RAS Piyasada 8.01.0003 Northern Ireland 2026-06-29T13:31:02.357Z 06959094210649 B-06959094210649 06959094210649 AmoyDx® KRAS/NRAS/BRAF Mutations Detection Kit Amoy Diagnostics Co., LTD. CN-MF-000021843 QbD RepS BV BE-AR-000000040 IVD Genel IVDD W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER Piyasada 8.01.0033 Northern Ireland 2026-06-29T13:31:01.156Z 06959094210595 B-06959094210595 06959094210595 AmoyDx® EGFR 29 Mutations Detection Kit Amoy Diagnostics Co., LTD. CN-MF-000021843 QbD RepS BV BE-AR-000000040 IVD Genel IVDD W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER Piyasada 8.01.0004 Northern Ireland 2026-06-29T13:30:55.143Z 06959094210588 B-06959094210588 06959094210588 AmoyDx® Essential NGS Panel Amoy Diagnostics Co., LTD. CN-MF-000021843 QbD RepS BV BE-AR-000000040 IVD Genel IVDD W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER Piyasada 8.06.0002 Northern Ireland 2026-06-29T13:30:53.946Z 06959094210571 B-06959094210571 06959094210571 AmoyDx® ROS1 Gene Fusions Detection Kit Amoy Diagnostics Co., LTD. CN-MF-000021843 QbD RepS BV BE-AR-000000040 IVD Genel IVDD W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER Piyasada 8.01.0020 Northern Ireland 2026-06-29T13:30:52.743Z 06959094210564 B-06959094210564 06959094210564 AmoyDx® HRD Focus Panel Amoy Diagnostics Co., LTD. CN-MF-000021843 QbD RepS BV BE-AR-000000040 IVD Genel IVDD W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER Piyasada 8.06.0047 Northern Ireland 2026-06-29T13:30:51.564Z 06959094210557 B-06959094210557 06959094210557 AmoyDx® HANDLE Classic NGS Panel Amoy Diagnostics Co., LTD. CN-MF-000021843 QbD RepS BV BE-AR-000000040 IVD Genel IVDD W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER Piyasada 8.06.0020 Northern Ireland 2026-06-29T13:30:45.546Z 06959094210519 B-06959094210519 06959094210519 AmoyDx® BRCA Pro Panel Amoy Diagnostics Co., LTD. CN-MF-000021843 QbD RepS BV BE-AR-000000040 IVD Genel IVDD W01060203 BRCA 1+2 Piyasada 8.06.0104 Northern Ireland 2026-06-29T13:30:44.357Z 06959094210489 69590942A0011G5 06959094210489 AmoyDx® FFPE DNA Kit Amoy Diagnostics Co., LTD. CN-MF-000021843 QbD RepS BV BE-AR-000000040 IVD Sınıf A IVDR 2017/746 W050299 DEVICES FOR SAMPLES TRANSPORT - OTHER Piyasada 8.02.0001 Northern Ireland 2026-06-29T13:30:43.164Z 06959094210472 69590942A0010G3 06959094210472 AmoyDx® Circulating DNA Kit Amoy Diagnostics Co., LTD. CN-MF-000021843 QbD RepS BV BE-AR-000000040 IVD Sınıf A IVDR 2017/746 W050299 DEVICES FOR SAMPLES TRANSPORT - OTHER Piyasada 8.02.0004 Northern Ireland 2026-06-29T13:30:41.948Z 06959094210465 69590942A0009GJ 06959094210465 AmoyDx® FFPE RNA Kit Amoy Diagnostics Co., LTD. CN-MF-000021843 QbD RepS BV BE-AR-000000040 IVD Sınıf A IVDR 2017/746 W050299 DEVICES FOR SAMPLES TRANSPORT - OTHER Piyasada 8.02.0003 Northern Ireland 2026-06-29T13:30:35.937Z 06959094210458 69590942A0008GG 06959094210458 AmoyDx® Magnetic FFPE DNA Extraction Kit Amoy Diagnostics Co., LTD. CN-MF-000021843 QbD RepS BV BE-AR-000000040 IVD Sınıf A IVDR 2017/746 W050299 DEVICES FOR SAMPLES TRANSPORT - OTHER Piyasada 8.02.0098 Northern Ireland 2026-06-29T13:30:34.743Z 06959094210441 69590942A0007GE 06959094210441 AmoyDx® Blood/Bone Marrow DNA Kit Amoy Diagnostics Co., LTD. CN-MF-000021843 QbD RepS BV BE-AR-000000040 IVD Sınıf A IVDR 2017/746 W050299 DEVICES FOR SAMPLES TRANSPORT - OTHER Piyasada 8.02.0077 Northern Ireland 2026-06-29T13:30:33.532Z 06959094210434 69590942A0006GC 06959094210434 AmoyDx® Tissue RNA Kit Amoy Diagnostics Co., LTD. CN-MF-000021843 QbD RepS BV BE-AR-000000040 IVD Sınıf A IVDR 2017/746 W050299 DEVICES FOR SAMPLES TRANSPORT - OTHER Piyasada 8.02.0079 Northern Ireland 2026-06-29T13:30:32.341Z 06959094210427 69590942A0005GA 06959094210427 AmoyDx® Tissue DNA Kit Amoy Diagnostics Co., LTD. CN-MF-000021843 QbD RepS BV BE-AR-000000040 IVD Sınıf A IVDR 2017/746 W050299 DEVICES FOR SAMPLES TRANSPORT - OTHER Piyasada 8.02.0078 Northern Ireland 2026-06-29T13:30:26.334Z 06959094210410 69590942A0004G8 06959094210410 AmoyDx® FFPE DNA/RNA Kit Amoy Diagnostics Co., LTD. CN-MF-000021843 QbD RepS BV BE-AR-000000040 IVD Sınıf A IVDR 2017/746 W050299 DEVICES FOR SAMPLES TRANSPORT - OTHER Piyasada 8.02.0002 Northern Ireland 2026-06-29T13:30:25.132Z 06959094210281 B-06959094210281 06959094210281 ANDAS Software Amoy Diagnostics Co., LTD. CN-MF-000021843 QbD RepS BV BE-AR-000000040 IVD Genel IVDD W02079082 VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - SOFTWARE ACCESSORIES Piyasada 8.06.0109 Northern Ireland 2026-06-29T13:30:23.936Z 06959094210274 B-06959094210274 06959094210274 AmoyDx® HRD Complete Panel Amoy Diagnostics Co., LTD. CN-MF-000021843 QbD RepS BV BE-AR-000000040 IVD Genel IVDD W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER Piyasada 8.06.0115 Northern Ireland 2026-06-29T13:30:22.730Z 06959094206192 B-06959094206192 06959094206192 AmoyDx® KRAS/NRAS Mutations Detection Kit Amoy Diagnostics Co., LTD. CN-MF-000021843 QbD RepS BV BE-AR-000000040 IVD Genel IVDD W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER Piyasada 8.01.0179 Northern Ireland 2026-06-29T13:30:16.723Z 06959094206154 B-06959094206154 06959094206154 AmoyDx® KRAS Mutation Detection Kit Amoy Diagnostics Co., LTD. CN-MF-000021843 QbD RepS BV BE-AR-000000040 IVD Genel IVDD W01060202 K-RAS Piyasada 8.01.0128 Northern Ireland 2026-06-29T13:30:15.516Z