HX 2041633-1 refdata.certificate-ivdr-type.quality-management-system refdata.certificate-status.issued Jiangsu Rongye Technology Co., Ltd. CN-MF-000019627 0197 2025-04-25T00:00:00 2030-04-24T00:00:00 true 2026-05-24T21:19:57.146Z HX 2048822-1 refdata.certificate-ivdr-type.quality-management-system refdata.certificate-status.supplemented Tosoh Corporation JP-MF-000024143 0197 2026-02-10T00:00:00 2029-09-12T00:00:00 true 2026-05-24T21:19:56.442Z HX 2055510-1 refdata.certificate-ivdr-type.quality-management-system refdata.certificate-status.amended WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD. CN-MF-000019908 0197 2025-07-01T00:00:00 2029-03-21T00:00:00 true 2026-05-24T21:19:56.355Z HX 2068816-1 refdata.certificate-ivdr-type.quality-management-system refdata.certificate-status.issued Weihai Hongyu Medical Devices Co., Ltd CN-MF-000007471 0197 2025-09-29T00:00:00 2030-09-28T00:00:00 true 2026-05-24T21:19:56.283Z HX 2074650-1 refdata.certificate-ivdr-type.quality-management-system refdata.certificate-status.supplemented Assure Tech. (Hangzhou) Co., Ltd. CN-MF-000002170 0197 2026-03-17T00:00:00 2029-06-12T00:00:00 true 2026-05-24T21:19:56.212Z HX 2161803-1 refdata.certificate-ivdr-type.quality-management-system refdata.certificate-status.cancelled Shijiazhuang Yuanding Medical Device Co.,LTD CN-MF-000010432 0197 2024-08-23T00:00:00 2029-08-22T00:00:00 true 2026-05-24T21:19:55.473Z HX 2165478-1 refdata.certificate-ivdr-type.quality-management-system refdata.certificate-status.issued Beijing Strong Biotechnologies, Inc. CN-MF-000004362 0197 2025-09-11T00:00:00 2030-09-10T00:00:00 true 2026-05-24T21:19:55.385Z HX 2173907-1 refdata.certificate-ivdr-type.quality-management-system refdata.certificate-status.issued Weihai Sunway Medical Technology Co.,Ltd CN-MF-000025939 0197 2025-05-09T00:00:00 2030-05-08T00:00:00 true 2026-05-24T21:19:54.639Z HX 2176150-1 refdata.certificate-ivdr-type.quality-management-system refdata.certificate-status.amended Genomictree, Inc. KR-MF-000037890 0197 2026-02-09T00:00:00 2031-01-05T00:00:00 true 2026-05-24T21:19:53.899Z HX 2183501-1 refdata.certificate-ivdr-type.quality-management-system refdata.certificate-status.issued Shenzhen Dymind Biotechnology Co., Ltd. CN-MF-000024842 0197 2024-06-14T00:00:00 2029-06-13T00:00:00 true 2026-05-24T21:19:53.812Z HX 2233216-1 refdata.certificate-ivdr-type.quality-management-system refdata.certificate-status.issued One Lambda, Inc. US-MF-000024901 0197 2025-10-29T00:00:00 2030-10-28T00:00:00 true 2026-05-24T21:19:53.726Z HX 2262557-1 refdata.certificate-ivdr-type.quality-management-system refdata.certificate-status.issued Epocal Inc. CA-MF-000017182 0197 2023-06-10T00:00:00 2026-12-31T00:00:00 true 2026-05-24T21:19:52.932Z HX 2423456-1 refdata.certificate-ivdr-type.quality-management-system refdata.certificate-status.issued INTIN Inc. KR-MF-000030877 0197 2025-03-17T00:00:00 2030-03-16T00:00:00 true 2026-05-24T21:19:52.187Z HX 2469808-1 refdata.certificate-ivdr-type.quality-management-system refdata.certificate-status.amended Guangzhou Brilliance Medical Technology Co., Ltd CN-MF-000017988 0197 2025-07-11T00:00:00 2029-10-24T00:00:00 true 2026-05-24T21:19:52.114Z HX 2512862-1 refdata.certificate-ivdr-type.quality-management-system refdata.certificate-status.issued VELLAP Diagnostics GmbH DE-MF-000035636 0197 2025-07-24T00:00:00 2030-07-23T00:00:00 true 2026-05-24T21:19:52.042Z HX 2534915-1 refdata.certificate-ivdr-type.quality-management-system refdata.certificate-status.issued Acmex Bio-Technology (Chongqing) Co., Ltd. CN-MF-000037745 0197 2025-11-13T00:00:00 2030-11-12T00:00:00 true 2026-05-24T21:19:51.252Z HX 2566030-1 refdata.certificate-ivdr-type.quality-management-system refdata.certificate-status.issued Zhejiang Greylynx Biotech Co., Ltd. CN-MF-000032462 0197 2025-03-13T00:00:00 2030-03-12T00:00:00 true 2026-05-24T21:19:51.164Z HX 256606-1 refdata.certificate-ivdr-type.quality-management-system refdata.certificate-status.issued WELLS BIO, INC. KR-MF-000031789 0197 2025-08-25T00:00:00 2030-07-31T00:00:00 true 2026-05-24T21:19:50.373Z HX 2608945-1 refdata.certificate-ivdr-type.quality-management-system refdata.certificate-status.issued DROPHIL BIOTECH (SHENZHEN) COMPANY LIMITED CN-MF-000042193 0197 2025-12-16T00:00:00 2030-12-15T00:00:00 true 2026-05-24T21:19:50.282Z HX 2626791-1 refdata.certificate-ivdr-type.quality-management-system refdata.certificate-status.issued Shenzhen CoooSeee Biomedical Co., Ltd. CN-MF-000045646 0197 2025-11-14T00:00:00 2030-11-13T00:00:00 true 2026-05-24T21:19:49.565Z