Biohermes Co., Ltd.
ChinaFDA applicant, unverified
- Devices
- 1
What Biohermes Co., Ltd. makes
Biohermes Co., Ltd. manufactures the A1C EZ Glycohemoglobin Analysis System, a device designed for measuring hemoglobin A1C levels in blood samples to monitor long-term blood glucose control in diabetes management.
The A1C EZ Glycohemoglobin Analysis System is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
A1C EZ Glycohemoglobin Analysis System Ref K161533
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biohermes Co., Ltd. have in the registry?
The registry currently lists 1 device for Biohermes Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biohermes Co., Ltd.'s devices?
Among its 1 most recently registered device, Biohermes Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Biohermes Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Biohermes Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biohermes Co., Ltd. in the registry?
The most recently registered devices listed for Biohermes Co., Ltd. include A1C EZ Glycohemoglobin Analysis System.