# DEN250006: Amferia Wound Dressing

- Pathway: De Novo (Direct)
- Applicant: Amferia AB
- Decided: Feb 6, 2026 after 340 days
- Product code: SHA (Solid Wound Dressing With Permanently Bound Antimicrobial Agent)
- Device class: 2
- Regulation: 21 CFR 878.4013
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
Amferia Wound Dressing is intended to cover and protect dry-to-low exuding wounds (e.g. abrasions, skin tears, lacerations, incisions and surgical wounds, superficial and partial-thickness burns, pressure ulcers, arterial ulcers), and to maintain an appropriate moisture balance within the wound.

Source page: https://510kreport.com/device/DEN250006
Methodology: https://510kreport.com/methodology