Shanghai Lange Medtech Co., Ltd.
ChinaFDA applicant, unverified FDA FEI 3035858921
- Devices
- 11
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Shanghai Lange Medtech Co., Ltd. makes
Shanghai Lange Medtech Co., Ltd. manufactures kyphoplasty balloon dilatation catheters, which are used in spinal procedures to expand vertebral bodies and restore structural integrity during vertebroplasty or kyphoplasty interventions.
The company’s devices are classified as Class II under FDA regulations and are listed in the 510(k) clearance registry. The manufacturer operates from the United States.
Catalogue
Search and filter all 11 devicesCompany details
- FDA FEI number
- 3035858921
- DUNS number
- 549889938
- Address
- 1st floor, Building 22, 1500 Duhui Road, Minhang District, Shanghai
Frequently asked questions
How many devices does Shanghai Lange Medtech Co., Ltd. have in the registry?
The registry currently lists 11 devices for Shanghai Lange Medtech Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shanghai Lange Medtech Co., Ltd.'s devices?
Among its 11 most recently registered devices, Shanghai Lange Medtech Co., Ltd. has devices listed in FDA 510(k) (1 device) and FDA GUDID (10 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Shanghai Lange Medtech Co., Ltd.'s devices fall under?
Among its 11 most recently registered devices, the classes recorded for Shanghai Lange Medtech Co., Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Shanghai Lange Medtech Co., Ltd. in the registry?
The most recently registered devices listed for Shanghai Lange Medtech Co., Ltd. include Bone Drills S04-34, Puncture Needles S05-02, Bone Cement Filler Devices S03-01 and Kyphoplasty Balloon Dilatation Catheters S01-1615.