Registered establishment in Suzhou, Jiangsu, China. 4 device types, 2 clearances.
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Calibrator, Secondary, Nephelometer, For Clinical Use and 2 other device types. Its earliest product listing with the FDA dates from 1999.
Registration
FDA registration record for Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | Registered name | BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD. |
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3027977508 |
| FEI number | 3027977508 |
| Establishment type | Contract manufacturer, Specification developer, Manufacturer |
Chinese Registration
Chinese company register details for Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | Chinese legal name | 贝克曼库尔特实验系统（苏州）有限公司 |
| Source | Qichacha company register |
Location
Address of Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | City | Suzhou |
| Province | Jiangsu |
| Address | No.11, Zhensheng Road, Suzhou Industrial Park |
| Postal code | 215126 |
| Country | China |
Group
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. is one of 2 plants registered under BECKMAN COULTER, INC..
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
From the Company
Published by the company on its own website, not by the FDA.
Information published by Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | Main products | in vitro diagnostic reagents, clinical analysis instruments, life science research reagents, laboratory diagnostic systems |
| Export markets | global |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.