05745000468423 5745000468EU02000500019R BGI BGI EUROPE A/S DK-MF-000014089 IVD Sınıf A UNKNOWN W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800) Piyasada EU0200050002 (PBC20A) Denmark 2026-06-22T02:14:26.771Z 05745000468430 5745000468EU02000500019R BGI BGI EUROPE A/S DK-MF-000014089 IVD Sınıf A UNKNOWN W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800) Piyasada EU0200050003 (PBC22) Denmark 2026-06-22T02:14:26.748Z 05745000468447 5745000468EU02000500019R BGI BGI EUROPE A/S DK-MF-000014089 IVD Sınıf A UNKNOWN W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800) Piyasada EU0200050004 (PBC22A) Denmark 2026-06-22T02:14:26.723Z 05745000468454 5745000468EU02000500019R BGI BGI EUROPE A/S DK-MF-000014089 IVD Sınıf A UNKNOWN W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800) Piyasada EU0200050005 (PBC20 Plus) Denmark 2026-06-22T02:14:26.693Z 05745000468461 5745000468EU02000500019R BGI BGI EUROPE A/S DK-MF-000014089 IVD Sınıf A UNKNOWN W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800) Piyasada EU0200050006 (PBC20A Plus) Denmark 2026-06-22T02:14:26.667Z 05745000468478 5745000468EU02000500019R BGI BGI EUROPE A/S DK-MF-000014089 IVD Sınıf A UNKNOWN W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800) Piyasada EU0200050007 (PBC22 Plus) Denmark 2026-06-22T02:14:26.641Z 05745000468485 5745000468EU02000500019R BGI BGI EUROPE A/S DK-MF-000014089 IVD Sınıf A UNKNOWN W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800) Piyasada EU0200050008 (PBC22A Plus) Denmark 2026-06-22T02:14:26.616Z 06975096611093 697509661MSC001P5 Automated Chemistry Analyzer Ningbo MedicalSystem Biotechnology Co., Ltd. CN-MF-000014369 RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202 IVD Sınıf A IVDR 2017/746 W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800) Piyasada B68010A 2026-06-16T09:39:59.970Z 06975096611154 697509661MSC001P5 Automated Chemistry Analyzer Ningbo MedicalSystem Biotechnology Co., Ltd. CN-MF-000014369 RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202 IVD Sınıf A IVDR 2017/746 W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800) Piyasada B48010A 2026-06-16T09:39:59.957Z 06975519630687 6975519630001B5C Vivadiag VivaChek Biotech (Hangzhou) Co., Ltd. CN-MF-000012160 Lotus NL B.V. NL-AR-000000121 IVD Sınıf A IVDR 2017/746 W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800) Artık piyasada değil LC-113-1 2026-06-16T09:29:23.629Z 08033622964469 0803362296444U8 BT 4500S S/ISE Biotecnica Instruments S.r.l. IT-MF-000008115 IVD Sınıf A IVDR 2017/746 W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800) Piyasada BT4500S S/I-E 2026-06-16T05:04:24.183Z 08033622964476 0803362296444U8 BT 4500S S/ISE Biotecnica Instruments S.r.l. IT-MF-000008115 IVD Sınıf A IVDR 2017/746 W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800) Piyasada BT4500S S/I-C 2026-06-16T05:04:24.166Z 08033622964506 0803362296444U8 BT 4500S S/ISE Biotecnica Instruments S.r.l. IT-MF-000008115 IVD Sınıf A IVDR 2017/746 W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800) Piyasada BT4500S S/I-A 2026-06-16T05:04:24.125Z 08033622964513 0803362296444U8 BT 4500S S/ISE Biotecnica Instruments S.r.l. IT-MF-000008115 IVD Sınıf A IVDR 2017/746 W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800) Piyasada BT4500S S/I-B 2026-06-16T05:04:24.103Z 08033622964520 0803362296444U8 BT 4500S S/ISE Biotecnica Instruments S.r.l. IT-MF-000008115 IVD Sınıf A IVDR 2017/746 W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800) Piyasada BT4500S S/I-D 2026-06-16T05:04:24.082Z 08033622964537 0803362296444U8 BT 4500S S/ISE Biotecnica Instruments S.r.l. IT-MF-000008115 IVD Sınıf A IVDR 2017/746 W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800) Piyasada BT4500S S/I-F 2026-06-16T05:04:24.061Z 08033622964599 0803362296483UJ 08033622964599 Biotecnica Instruments S.r.l. IT-MF-000008115 IVD Sınıf A IVDR 2017/746 W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800) Piyasada BT 4500V-A-B 2026-06-16T05:04:24.003Z 08033622964605 0803362296483UJ 08033622964605 Biotecnica Instruments S.r.l. IT-MF-000008115 IVD Sınıf A IVDR 2017/746 W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800) Piyasada BT 4500V-A-C 2026-06-16T05:04:23.981Z 08033622964612 0803362296483UJ 08033622964612 Biotecnica Instruments S.r.l. IT-MF-000008115 IVD Sınıf A IVDR 2017/746 W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800) Piyasada BT 4500V-B-A 2026-06-16T05:04:23.963Z 08033622964629 0803362296483UJ 08033622964629 Biotecnica Instruments S.r.l. IT-MF-000008115 IVD Sınıf A IVDR 2017/746 W0201010102 CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800) Piyasada BT 4500V-B-C 2026-06-16T05:04:23.946Z