Manufacturer and brand owner in Wuxi, Jiangsu, China. 3 device types, 20 products catalogued.
Wuxi Biohermes BIO & Medical Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Assay, Glycosylated Hemoglobin, Immunoassay, Insulin-Like Growth Factor Binding Protein-1 and 1 other device type. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2016.
Registration
FDA registration record for Wuxi Biohermes BIO & Medical Technology Co., Ltd. | Registered name | WUXI BIOHERMES BIO & MEDICAL TECHNOLOGY CO., LTD. |
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3012526002 |
| FEI number | 3012526002 |
| DUNS | 528192913 |
| Establishment type | Manufacturer |
Chinese Registration
Chinese company register details for Wuxi Biohermes BIO & Medical Technology Co., Ltd. | Chinese legal name | 无锡博慧斯生物医药科技有限公司 |
| Unified social credit code | 91320211793310403C |
| Source | NMPA UDI database |
Location
Address of Wuxi Biohermes BIO & Medical Technology Co., Ltd. | City | Wuxi |
| Province | Jiangsu |
| Address | No.136 Mashan Meiliang Road,Binhu |
| Postal code | 214092 |
| Country | China |
Clearances
No clearance names Wuxi Biohermes BIO & Medical Technology Co., Ltd. as applicant. One is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
From the Company
Published by the company on its own website, not by the FDA.
Information published by Wuxi Biohermes BIO & Medical Technology Co., Ltd. | Founded | 2006 |
| Employees | 200 |
| Factory area | 5000 |
| Main products | HbA1c analyzers, COVID-19 tests, Blood glucose meters, SARS-CoV-2 antigen tests, Obstetrics and gynecology products |
| Certifications | CE, ISO13485 |
| Export markets | 100+ countries |
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.