Data / Medical devices / China / Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Wuxi Biohermes Bio & Medical Technology Co., Ltd.: FDA-registered device maker in Wuxi Jiangsu, China, 1 510(k) clearance
Wuxi Biohermes Bio & Medical Technology Co., Ltd. is registered with the FDA (registration 3012526002) in Wuxi Jiangsu, China. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 16, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012526002
- Address
- No.136 Mashan Meiliang Road,Binhu, Wuxi Jiangsu, China, 214092
- Owner or operator
- Wuxi Biohermes Bio & Medical Technology Co., Ltd. (10051365)
- Roles
- Manufacturer
- First device listed
- March 7, 2016
- Registered through
- 2026
- Brand names listed
- BioHermes, A1C EZ Glycohemoglobin Analysis System, model A1C EZ 2, Insulin-like Growth Factor Binding Protein-1 Test Kit(Colloidal Gold)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 | Manufacturer | accessdata.fda.gov |
| Assay, Glycosylated Hemoglobin | LCP | 2 | Manufacturer | accessdata.fda.gov |
| Immunoassay, Insulin-Like Growth Factor Binding Protein-1 | OAM | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 16, 2017 | K161533 | A1C EZ Glycohemoglobin Analysis System | LCP | Substantially Equivalent | Biohermes Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Immunoassay, Insulin-Like Growth Factor Binding Protein-1
- All makers of Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- All makers of Assay, Glycosylated Hemoglobin
Updated June 16, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.