Shenzhen Hexin Zondan Medical Equipment Co., Ltd.
ChinaFDA applicant, unverified FDA
- Devices
- 7
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Shenzhen Hexin Zondan Medical Equipment Co., Ltd. makes
Shenzhen Hexin Zondan Medical Equipment Co., Ltd. manufactures pulse oximeters, which are non-invasive devices used to measure oxygen saturation levels in a patient’s blood and pulse rate.
The company’s pulse oximeters are regulated as Class II devices under the FDA’s 510(k) pathway and are listed in the U.S. regulatory database.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
Pulse Oximeter Ref K203854
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 527098717
FDA establishments
- Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd Shenzhen Guangdong · CN FEI 3007858728
Frequently asked questions
How many devices does Shenzhen Hexin Zondan Medical Equipment Co., Ltd. have in the registry?
The registry currently lists 7 devices for Shenzhen Hexin Zondan Medical Equipment Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shenzhen Hexin Zondan Medical Equipment Co., Ltd.'s devices?
Among its 7 most recently registered devices, Shenzhen Hexin Zondan Medical Equipment Co., Ltd. has devices listed in FDA 510(k) (1 device) and FDA GUDID (6 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Shenzhen Hexin Zondan Medical Equipment Co., Ltd.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Shenzhen Hexin Zondan Medical Equipment Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Shenzhen Hexin Zondan Medical Equipment Co., Ltd. in the registry?
The most recently registered devices listed for Shenzhen Hexin Zondan Medical Equipment Co., Ltd. include AccuMed AC-D1, Homedics PX-200L, Homedics PX-250RCO and Homedics PX-250HCO.
Which FDA establishments are linked to Shenzhen Hexin Zondan Medical Equipment Co., Ltd.?
1 FDA establishment is linked to Shenzhen Hexin Zondan Medical Equipment Co., Ltd. in the registry; they are listed on the company page.