Supermax Healthcare Canada-Supermax Medical
CanadaFDA applicant, unverified
- Devices
- 2
What Supermax Healthcare Canada-Supermax Medical makes
Supermax Medical produces ASTM-certified surgical masks, including Aurelia Surgical Masks at ASTM Level 1, Level 2, and Level 3 (2130). These products are designed for medical and surgical use to meet specific filtration and barrier performance standards.
The company’s surgical masks are classified as Class II devices under FDA regulations and are supported by 510(k) clearances. The portfolio is listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Aurelia Surgical Mask ASTM Level-3 (2130) Ref K242502
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Supermax Healthcare Canada-Supermax Medical have in the registry?
The registry currently lists 2 devices for Supermax Healthcare Canada-Supermax Medical. Devices recorded under merged duplicate company entries are counted once.
Which registries list Supermax Healthcare Canada-Supermax Medical's devices?
Among its 2 most recently registered devices, Supermax Healthcare Canada-Supermax Medical has devices listed in FDA 510(k) (2 devices).
What risk classes do Supermax Healthcare Canada-Supermax Medical's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Supermax Healthcare Canada-Supermax Medical's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Supermax Healthcare Canada-Supermax Medical in the registry?
The most recently registered devices listed for Supermax Healthcare Canada-Supermax Medical include Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2 and Aurelia Surgical Mask ASTM Level-3 (2130).