Welspun India Limited
IndiaFDA applicant, unverified
- Devices
- 1
What Welspun India Limited makes
Welspun India Limited manufactures surgical masks, designed for single-use in medical and healthcare settings to provide barrier protection against airborne contaminants and splashes.
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
Welspun Health Surgical Mask Ref K211536
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Welspun India Limited have in the registry?
The registry currently lists 1 device for Welspun India Limited. Devices recorded under merged duplicate company entries are counted once.
Which registries list Welspun India Limited's devices?
Among its 1 most recently registered device, Welspun India Limited has devices listed in FDA 510(k) (1 device).
What risk classes do Welspun India Limited's devices fall under?
Among its 1 most recently registered device, the classes recorded for Welspun India Limited's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Welspun India Limited in the registry?
The most recently registered devices listed for Welspun India Limited include Welspun Health Surgical Mask.