Amphastar Nanjing Pharmaceuticals, Inc.
ChinaFDA applicant, unverified
- Devices
- 1
What Amphastar Nanjing Pharmaceuticals, Inc. makes
Amphastar Nanjing Pharmaceuticals, Inc. manufactures surgical face masks designed for single-use in medical and surgical settings to reduce the risk of airborne contamination during procedures.
The company’s products are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Surgical Face Mask Ref K201545
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Amphastar Nanjing Pharmaceuticals, Inc. have in the registry?
The registry currently lists 1 device for Amphastar Nanjing Pharmaceuticals, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Amphastar Nanjing Pharmaceuticals, Inc.'s devices?
Among its 1 most recently registered device, Amphastar Nanjing Pharmaceuticals, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Amphastar Nanjing Pharmaceuticals, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Amphastar Nanjing Pharmaceuticals, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Amphastar Nanjing Pharmaceuticals, Inc. in the registry?
The most recently registered devices listed for Amphastar Nanjing Pharmaceuticals, Inc. include Surgical Face Mask.