Suzhou Janee Medical Technology Co., Ltd.
ChinaFDA applicant, unverified
- Devices
- 2
What Suzhou Janee Medical Technology Co., Ltd. makes
Suzhou Janee Medical Technology Co., Ltd. manufactures disposable surgical gowns and surgical face masks, designed for single-use in clinical and procedural settings to maintain infection control standards.
These products are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Disposable Surgical Gown Ref K212591
Regimes: 510(k) Registry: 510(k)Surgical Face Mask Ref K212526
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Suzhou Janee Medical Technology Co., Ltd. have in the registry?
The registry currently lists 2 devices for Suzhou Janee Medical Technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Suzhou Janee Medical Technology Co., Ltd.'s devices?
Among its 2 most recently registered devices, Suzhou Janee Medical Technology Co., Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Suzhou Janee Medical Technology Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Suzhou Janee Medical Technology Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Suzhou Janee Medical Technology Co., Ltd. in the registry?
The most recently registered devices listed for Suzhou Janee Medical Technology Co., Ltd. include Disposable Surgical Gown and Surgical Face Mask.