Shenzhen Harveymed Technology Co., Ltd.
ChinaFDA applicant, unverified FDA FEI 3033814505
- Devices
- 5
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Shenzhen Harveymed Technology Co., Ltd. makes
Shenzhen Harveymed Technology Co., Ltd. manufactures portable oxygen concentrators, including the V series models (V5, V5C, V6, V6C). These devices are designed to filter nitrogen from ambient air and deliver concentrated oxygen for patients requiring supplemental oxygen therapy on the move.
The company’s products fall under FDA Class II regulation and are listed via the 510(k) clearance pathway. The manufacturer is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3033814505
- DUNS number
- 708252479
- Address
- B203 Weike science and technology building, No. 20, Gaoxin West Road, Dongzhou community, Shenzhen Guangdong
Frequently asked questions
How many devices does Shenzhen Harveymed Technology Co., Ltd. have in the registry?
The registry currently lists 5 devices for Shenzhen Harveymed Technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shenzhen Harveymed Technology Co., Ltd.'s devices?
Among its 5 most recently registered devices, Shenzhen Harveymed Technology Co., Ltd. has devices listed in FDA 510(k) (1 device) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Shenzhen Harveymed Technology Co., Ltd.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Shenzhen Harveymed Technology Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Shenzhen Harveymed Technology Co., Ltd. in the registry?
The most recently registered devices listed for Shenzhen Harveymed Technology Co., Ltd. include HarveyMed V5C, HarveyMed V6, HarveyMed V6C and HarveyMed V5.