Rochal Industries, LLC
United StatesFDA applicant, unverified
- Devices
- 5
What Rochal Industries, LLC makes
Rochal Industries, LLC manufactures topical skin protectants, including non-sting and antimicrobial formulations designed for sensitive skin applications. Their portfolio also includes antimicrobial wound gels and cleansers for skin and wound care, as well as a silicone-based barrier film for wound protection.
The company’s products are regulated under FDA Class I and Class II (Unclassified) devices, with several authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) database and are based in the United States.
Catalogue
Atteris No-Sting Skin Protectant Ref K160684
Regimes: 510(k) Registry: 510(k)Atteris Antimicrobial Skin Protectant Ref K161212
Regimes: 510(k) Registry: 510(k)Rochal Antimicrobial Wound Gel Ref K192527
Regimes: 510(k) Registry: 510(k)Atteris Antimicrobial Skin & Wound Cleanser Ref K160192
Regimes: 510(k) Registry: 510(k)Rochal Bioshield Silicone Film Ref K182733
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Rochal Industries, LLC have in the registry?
The registry currently lists 5 devices for Rochal Industries, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rochal Industries, LLC's devices?
Among its 5 most recently registered devices, Rochal Industries, LLC has devices listed in FDA 510(k) (5 devices).
What risk classes do Rochal Industries, LLC's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Rochal Industries, LLC's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Rochal Industries, LLC in the registry?
The most recently registered devices listed for Rochal Industries, LLC include Atteris No-Sting Skin Protectant, Atteris Antimicrobial Skin Protectant, Rochal Antimicrobial Wound Gel and Atteris Antimicrobial Skin & Wound Cleanser.