Wellmien (Suzhou) Import & Export Trading Co., Ltd.
Country not established
- Devices
- 1
What Wellmien (Suzhou) Import & Export Trading Co., Ltd. makes
Wellmien produces surgical masks designed for medical use, intended to protect healthcare workers and patients from airborne contaminants during surgical procedures.
The company’s surgical masks are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway in the United States.
Catalogue
Wellmien Surgical Mask Ref K101000
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Wellmien (Suzhou) Import & Export Trading Co., Ltd. have in the registry?
The registry currently lists 1 device for Wellmien (Suzhou) Import & Export Trading Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Wellmien (Suzhou) Import & Export Trading Co., Ltd.'s devices?
Among its 1 most recently registered device, Wellmien (Suzhou) Import & Export Trading Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Wellmien (Suzhou) Import & Export Trading Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Wellmien (Suzhou) Import & Export Trading Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Wellmien (Suzhou) Import & Export Trading Co., Ltd. in the registry?
The most recently registered devices listed for Wellmien (Suzhou) Import & Export Trading Co., Ltd. include WELLMIEN SURGICAL MASK.