06926980316938 69269803YQKaeser6800X3 06926980316938 Automated Chemiluminescence Immunoassay Analyzer Guangzhou Kangrun Biotech Co., Ltd. CN-MF-000032267 Sungo Cert GmbH DE-AR-000010869 IVD Sınıf A IVDR 2017/746 W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h) Piyasada CK-KR-CLIA-007 Austria 2026-07-31T15:42:19.874Z 06925912715245 692591270180HE 06925912715245 iFlash 9000 CLIA Analyzer SHENZHEN YHLO BIOTECH CO., LTD. CN-MF-000001137 Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001 IVD Sınıf A IVDR 2017/746 W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h) Piyasada FG0076 Italy 2026-07-31T15:34:45.876Z 06925912710431 692591270141H4 06925912710431 Chemiluminescence Immunoassay Analyzer SHENZHEN YHLO BIOTECH CO., LTD. CN-MF-000001137 Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001 IVD Sınıf A IVDR 2017/746 W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h) Piyasada C6106 Italy 2026-07-31T15:28:39.379Z 06925794520036 69257945W0201020103D0KA CM-320i Chemiluminescence Immunoassay Analyzer Chemiluminescence Immunoassay Analyzer DIRUI INDUSTRIAL CO., LTD CN-MF-000001891 SUNGO Europe B.V. NL-AR-000000247 IVD Sınıf A IVDR 2017/746 W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h) Piyasada 3013370 Austria 2026-07-31T15:27:41.357Z 15099590265373 150995901UniCelDxI8Z UniCel DxI 800 Access Immunoassay System UniCel DxI 800 Access Immunoassay System Beckman Coulter Inc. US-MF-000010288 Beckman Coulter Ireland Inc. IE-AR-000000886 IVD Sınıf A IVDR 2017/746 W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h) Piyasada 973100 Ireland 2026-07-30T17:35:31.805Z 00630414002026 0405686901509VM Atellica IM 1600 Analyzer IVDR_67_TTN_DUB-C_A_INST_1600 Analyzer Siemens Healthcare Diagnostics Inc. US-MF-000016560 Siemens Healthcare Diagnostics Manufacturing Limited IE-AR-000006763 IVD Sınıf A IVDR 2017/746 W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h) Piyasada 11066000 Belgium 2026-07-15T21:22:23.156Z 80536089444764 805360894ES0000859 Pulsar 350 Pulsar 350 - Automated Immunochemistry Analyser Edif Instruments S.r.l. IT-MF-000009556 IVD Sınıf A IVDR 2017/746 W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h) Piyasada ES00008 Italy 2026-07-03T06:56:53.020Z 07813338158458 761333601561AR cobas e 801 analytical unit cobas e 801 analytical unit Hitachi High-Tech Corporation JP-MF-000016991 Roche Diagnostics GmbH DE-AR-000006262 IVD Sınıf A IVDR 2017/746 W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h) Piyasada 08454345001 Germany 2026-07-03T03:04:59.558Z 07613336158562 761333601562AT cobas e 801 MSB/MSBL cobas e 801 MSB/MSBL Hitachi High-Tech Corporation JP-MF-000016991 Roche Diagnostics GmbH DE-AR-000006262 IVD Sınıf A IVDR 2017/746 W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h) Piyasada 08459606 001 Germany 2026-07-03T02:59:40.644Z 15099590341602 150995901UniCelDxI8Z UniCel DxI 600 Access Immunoassay System Beckman Coulter Inc. US-MF-000010288 Beckman Coulter Ireland Inc. IE-AR-000000886 IVD Sınıf A UNKNOWN W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h) Piyasada A30260 2026-07-02T19:13:30.078Z 15099590369194 150995901UniCelDxI8Z UniCel DxI 800 Access Immunoassay System w/Spot B Beckman Coulter Inc. US-MF-000010288 Beckman Coulter Ireland Inc. IE-AR-000000886 IVD Sınıf A UNKNOWN W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h) Piyasada A71456 2026-07-02T19:13:29.999Z 15099590369224 150995901UniCelDxI8Z UniCel DxI 600 Access Immunoassay System w/Spot B Beckman Coulter Inc. US-MF-000010288 Beckman Coulter Ireland Inc. IE-AR-000000886 IVD Sınıf A UNKNOWN W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h) Piyasada A71460 2026-07-02T19:13:29.957Z 06975140171191 697514017Shinei3910HC Chemiluminescence Immunoassay Analyzer Chemiluminescence Immunoassay Analyzer Shenzhen Increcare Biotech Co., Ltd CN-MF-000027299 Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001 IVD Sınıf A IVDR 2017/746 W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h) Piyasada Shine i3910 Germany 2026-07-02T15:15:30.333Z 06975140171184 697514017Shinei3900H9 Chemiluminescence Immunoassay Analyzer Chemiluminescence Immunoassay Analyzer Shenzhen Increcare Biotech Co., Ltd CN-MF-000027299 Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001 IVD Sınıf A IVDR 2017/746 W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h) Piyasada Shine i3900 Germany 2026-07-02T15:15:28.737Z 06975140171177 697514017Shinei3920HF Chemiluminescence Immunoassay Analyzer Chemiluminescence Immunoassay Analyzer Shenzhen Increcare Biotech Co., Ltd CN-MF-000027299 Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001 IVD Sınıf A IVDR 2017/746 W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h) Piyasada Shine i3920 Germany 2026-07-02T15:15:26.329Z 06975140171146 697514017Shinei6910HZ Chemiluminescence Immunoassay Analyzer Chemiluminescence Immunoassay Analyzer Shenzhen Increcare Biotech Co., Ltd CN-MF-000027299 Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001 IVD Sınıf A IVDR 2017/746 W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h) Piyasada Shine i6910 Germany 2026-07-02T15:15:24.732Z 06975140171016 697514017Shinei6900HW Chemiluminescence Immunoassay Analyzer Chemiluminescence Immunoassay Analyzer Shenzhen Increcare Biotech Co., Ltd CN-MF-000027299 Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001 IVD Sınıf A IVDR 2017/746 W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h) Piyasada Shine i6900 Germany 2026-07-02T15:15:23.920Z 06974847810532 697484781008QE V150 Automatic Chemiluminescence Immunoassay Analyzer Automatic Chemiluminescence Immunoassay Analyzer Shanghai Kehua Laboratory System Co., Ltd. CN-MF-000017428 Obelis s.a. BE-AR-000000106 IVD Sınıf A IVDR 2017/746 W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h) Piyasada V150 Italy 2026-07-02T14:36:00.861Z 06973841000826 697384100B15004T Immunofluorescence Analyzer Immunofluorescence Analyzer Guangdong Wesail Biotech Co., Ltd. CN-MF-000008828 MedPath GmbH DE-AR-000000087 IVD Sınıf A IVDR 2017/746 W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h) Piyasada WS-Si1500 Germany 2026-07-02T12:01:31.913Z 06973841000789 697384100B100042 Immunofluorescence Analyzer Immunofluorescence Analyzer Guangdong Wesail Biotech Co., Ltd. CN-MF-000008828 MedPath GmbH DE-AR-000000087 IVD Sınıf A IVDR 2017/746 W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h) Piyasada WS-Si1000 Germany 2026-07-02T12:01:31.108Z