Andon Medical Co., Ltd.
ChinaFDA applicant, unverified FDA
- Devices
- 9
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Andon Medical Co., Ltd. makes
Andon Medical Co., Ltd. manufactures blood glucose monitoring systems, including standalone devices like the AG-608, AG-610, and AG-695 series, as well as wireless smart systems such as the iHealth BG5/BG5L. The company also produces fully automatic electronic blood pressure monitors (KD-5966 series) and healthcare management software designed to integrate with glucose monitoring systems, such as the Andon Healthcare Management System.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) registry. These products are intended for use in the United States, where regulatory compliance is required for medical devices.
Catalogue
Blood Glucose Monitoring System Ref K120813
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Andon Health Care Management System Software Ref K112738
Regimes: 510(k) Registry: 510(k)Andon Health Care Management System Software, AG-608 Single & AG-608 Multi Blood Glucose Monitoring Systems Ref K102678
Regimes: 510(k) Registry: 510(k)AG-608N Blood Glucose Monitoring System Ref K110017
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
FDA establishments
- Andon Medical co., LTD Tianjin · CN FEI 3008573045
Frequently asked questions
How many devices does Andon Medical Co., Ltd. have in the registry?
The registry currently lists 9 devices for Andon Medical Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Andon Medical Co., Ltd.'s devices?
Among its 9 most recently registered devices, Andon Medical Co., Ltd. has devices listed in FDA 510(k) (9 devices).
What risk classes do Andon Medical Co., Ltd.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Andon Medical Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Andon Medical Co., Ltd. in the registry?
The most recently registered devices listed for Andon Medical Co., Ltd. include BLOOD GLUCOSE MONITORING SYSTEM, AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM, IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM and AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM.
Which FDA establishments are linked to Andon Medical Co., Ltd.?
1 FDA establishment is linked to Andon Medical Co., Ltd. in the registry; they are listed on the company page.