Dragon Heart Medical Devices Co., Ltd.
Country not established FDA
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Dragon Heart Medical Devices Co., Ltd. makes
Dragon Heart Medical Devices Co., Ltd. manufactures intravenous (I.V.) administration sets and piston syringes, designed for fluid delivery and medication dispensing in clinical settings.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Dragon Heart I.V. Set Ref K043235
Regimes: 510(k) Registry: 510(k)Dragon Heart Piston Syringe Ref K042547
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Dragon Heart Medical Devices Co., Ltd. Kaiping Guangdong · CN FEI 3004215921
Frequently asked questions
How many devices does Dragon Heart Medical Devices Co., Ltd. have in the registry?
The registry currently lists 2 devices for Dragon Heart Medical Devices Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dragon Heart Medical Devices Co., Ltd.'s devices?
Among its 2 most recently registered devices, Dragon Heart Medical Devices Co., Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Dragon Heart Medical Devices Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Dragon Heart Medical Devices Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dragon Heart Medical Devices Co., Ltd. in the registry?
The most recently registered devices listed for Dragon Heart Medical Devices Co., Ltd. include DRAGON HEART I.V. SET and DRAGON HEART PISTON SYRINGE.
Which FDA establishments are linked to Dragon Heart Medical Devices Co., Ltd.?
1 FDA establishment is linked to Dragon Heart Medical Devices Co., Ltd. in the registry; they are listed on the company page.