06978465230406 697846523FACIAN3 06978465230406 Shenzhen Dake Medical Technology Co.,Ltd CN-MF-000047336 SUNGO Europe B.V. NL-AR-000000247 IVD Sınıf A IVDR 2017/746 W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) Piyasada N/A 2026-06-16T08:39:05.764Z 06978465230413 697846523FACIAN3 06978465230413 Shenzhen Dake Medical Technology Co.,Ltd CN-MF-000047336 SUNGO Europe B.V. NL-AR-000000247 IVD Sınıf A IVDR 2017/746 W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) Piyasada N/A 2026-06-16T08:39:05.745Z 06978465230420 697846523FACIAN3 06978465230420 Shenzhen Dake Medical Technology Co.,Ltd CN-MF-000047336 SUNGO Europe B.V. NL-AR-000000247 IVD Sınıf A IVDR 2017/746 W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) Piyasada N/A 2026-06-16T08:39:05.725Z 07333066001029 7333066BUDI0015LT Phadia 250 Phadia AB SE-MF-000014170 IVD Sınıf A IVDR 2017/746 W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) Piyasada 12-3900-01 2026-06-16T07:31:10.418Z 07333066001043 7333066BUDI0015LT Phadia 5000 Phadia AB SE-MF-000014170 IVD Sınıf A IVDR 2017/746 W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) Piyasada 12-4000-00 2026-06-16T07:31:10.380Z 07333066001067 7333066BUDI0015LT Phadia 2500 Phadia AB SE-MF-000014170 IVD Sınıf A IVDR 2017/746 W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) Piyasada 12-4100-00 2026-06-16T07:30:59.111Z 07333066016900 7333066BUDI0015LT Phadia 200 Phadia AB SE-MF-000014170 IVD Sınıf A IVDR 2017/746 W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) Piyasada 12-4300-00 2026-06-16T07:30:22.533Z 07333066020907 7333066BUDI0015LT Phadia 5000E Phadia AB SE-MF-000014170 IVD Sınıf A IVDR 2017/746 W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) Piyasada 12-4000-01 2026-06-16T07:30:21.325Z 07333066020914 7333066BUDI0015LT Phadia 5000E+E Phadia AB SE-MF-000014170 IVD Sınıf A IVDR 2017/746 W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) Piyasada 12-4000-02 2026-06-16T07:30:21.301Z 07333066020921 7333066BUDI0015LT Phadia 2500E Phadia AB SE-MF-000014170 IVD Sınıf A IVDR 2017/746 W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) Piyasada 12-4100-01 2026-06-16T07:30:21.283Z 07333066020938 7333066BUDI0015LT Phadia 2500EE Phadia AB SE-MF-000014170 IVD Sınıf A IVDR 2017/746 W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) Piyasada 12-4100-02 2026-06-16T07:30:21.264Z 07613336181225 7613336020049T cobas e 411 analyzer Language Pack – Japanese Version 3.2.1.ja_W10 Hitachi High-Tech Corporation JP-MF-000016991 Roche Diagnostics GmbH DE-AR-000006262 IVD Sınıf A IVDR 2017/746 W0201020182 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES Piyasada 09309438001 2026-06-16T06:33:10.306Z 07613336181232 7613336020049T cobas e 411 analyzer Language Pack – Polish Version 3.2.1.pl Hitachi High-Tech Corporation JP-MF-000016991 Roche Diagnostics GmbH DE-AR-000006262 IVD Sınıf A IVDR 2017/746 W0201020182 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES Piyasada 09309446001 2026-06-16T06:33:10.288Z 07613336181249 7613336020049T cobas e 411 analyzer Language Pack - Russian Version 3.2.1.ru Hitachi High-Tech Corporation JP-MF-000016991 Roche Diagnostics GmbH DE-AR-000006262 IVD Sınıf A IVDR 2017/746 W0201020182 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES Piyasada 09309454001 2026-06-16T06:33:10.270Z 07613336181256 7613336020049T cobas e 411 analyzer Language Pack – Chinese Version 3.2.1.zh_W10 Hitachi High-Tech Corporation JP-MF-000016991 Roche Diagnostics GmbH DE-AR-000006262 IVD Sınıf A IVDR 2017/746 W0201020182 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES Piyasada 09309462001 2026-06-16T06:33:10.251Z 07613336181263 7613336020049T cobas e 411 analyzer Language Pack – Czech Version 3.2.1 cs Hitachi High-Tech Corporation JP-MF-000016991 Roche Diagnostics GmbH DE-AR-000006262 IVD Sınıf A IVDR 2017/746 W0201020182 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES Piyasada 09309489001 2026-06-16T06:33:10.233Z 07613336181270 7613336020049T cobas e 411 analyzer Language Pack – Danish Version 3.2.1 da Hitachi High-Tech Corporation JP-MF-000016991 Roche Diagnostics GmbH DE-AR-000006262 IVD Sınıf A IVDR 2017/746 W0201020182 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES Piyasada 09309497001 2026-06-16T06:33:10.216Z 07613336183663 7613336020049T cobas e 411 analyzer Language Pack – French Version 3.2.1.fr Hitachi High-Tech Corporation JP-MF-000016991 Roche Diagnostics GmbH DE-AR-000006262 IVD Sınıf A IVDR 2017/746 W0201020182 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES Piyasada 09388079001 2026-06-16T06:33:10.198Z 07613336187159 761333601994BU cobas 8000 modular analyzer series Language Pack-German Hitachi High-Tech Corporation JP-MF-000016991 Roche Diagnostics GmbH DE-AR-000006262 IVD Sınıf A IVDR 2017/746 W0201020182 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES Piyasada 09432094001 2026-06-16T06:33:10.071Z 07613336187166 761333601994BU cobas 8000 modular analyzer series Language Pack-Spanish Hitachi High-Tech Corporation JP-MF-000016991 Roche Diagnostics GmbH DE-AR-000006262 IVD Sınıf A IVDR 2017/746 W0201020182 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES Piyasada 09432108001 2026-06-16T06:33:10.052Z