Dermaphylyx, Inc.
United StatesFDA applicant, unverified
- Devices
- 9
What Dermaphylyx, Inc. makes
Dermaphylyx, Inc. manufactures a range of wound dressings, including hydrocolloid, calcium alginate, hydrophilic foam, and super absorbent fiber dressings designed for acute and chronic wound care. Their portfolio also includes film wound dressings, foam island dressings, and skin protectors to prevent and treat skin breakdown. Additional products like DERMAFLEX and HEALIAFLEX foam dressings target exuding wounds and pressure injury prevention.
The company’s devices are classified under FDA’s Class I and Unclassified (U) categories, with most requiring 510(k) clearance. Products are listed in the FDA’s 510(k) registry, reflecting their regulatory status in the United States. The manufacturer is based in the US.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Dermaphylyx Super Absorbent Fiber Dressing Ref K991609
Regimes: 510(k) Registry: 510(k)Dermaphylyx Foam Island Dressing Ref K991933
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Dermaphylyx Hydrophilic Foam Wound Dressing Ref K991920
Regimes: 510(k) Registry: 510(k)Dermaphylyx Calcium Alginate Wound Dressing Ref K991608
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Dermaphylyx Calcium Alginate Wound Dressing Ref K991061
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Dermaphylyx, Inc. have in the registry?
The registry currently lists 9 devices for Dermaphylyx, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dermaphylyx, Inc.'s devices?
Among its 9 most recently registered devices, Dermaphylyx, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do Dermaphylyx, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Dermaphylyx, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Dermaphylyx, Inc. in the registry?
The most recently registered devices listed for Dermaphylyx, Inc. include DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING, DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING, DERMAPHYLYX FOAM ISLAND DRESSING and DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING.