Polymed (Xiamen) Plastic Industrial Co., Ltd.
ChinaFDA applicant, unverified FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Polymed (Xiamen) Plastic Industrial Co., Ltd. makes
Polymed (Xiamen) Plastic Industrial Co., Ltd. manufactures the SIMPLIFY COMPACT RESUSCITATOR, a portable manual resuscitation device designed for emergency use in clinical and pre-hospital settings.
The device is classified as Class II under FDA regulations and is listed via 510(k) clearance. The company is based in the United States.
Catalogue
Simplify Compact Resuscitator Ref K021716
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Polymed (Xiamen) Plastic Industrial Co., Ltd. XIAMEN Fujian · CN FEI 3003202124
Frequently asked questions
How many devices does Polymed (Xiamen) Plastic Industrial Co., Ltd. have in the registry?
The registry currently lists 1 device for Polymed (Xiamen) Plastic Industrial Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Polymed (Xiamen) Plastic Industrial Co., Ltd.'s devices?
Among its 1 most recently registered device, Polymed (Xiamen) Plastic Industrial Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Polymed (Xiamen) Plastic Industrial Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Polymed (Xiamen) Plastic Industrial Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Polymed (Xiamen) Plastic Industrial Co., Ltd. in the registry?
The most recently registered devices listed for Polymed (Xiamen) Plastic Industrial Co., Ltd. include SIMPLIFY COMPACT RESUSCITATOR.
Which FDA establishments are linked to Polymed (Xiamen) Plastic Industrial Co., Ltd.?
1 FDA establishment is linked to Polymed (Xiamen) Plastic Industrial Co., Ltd. in the registry; they are listed on the company page.