510(k) DEN250006

Amferia Wound Dressing by Amferia AB — Product Code SHA

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: February 6, 2026
Date Received: March 3, 2025
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Solid Wound Dressing With Permanently Bound Antimicrobial Agent
Device Class: Class II
Regulation Number: 878.4013
Review Panel: SU
Submission Type

A solid wound dressing with permanently bound antimicrobial agent consists of a solid wound dressing containing antimicrobial permanently bound to the substrate surface. The solid wound dressing is used to cover and protect a wound, to absorb exudate, and to maintain appropriate moisture balance within the wound and is intended for use only on external cutaneous (skin) wounds. The solid wound dressing is provided sterile in a form able to hold structural integrity. Antimicrobials are used for protectant purposes only to reduce microbial growth within the solid wound dressing while in use, or to provide an antimicrobial barrier to microbial penetration through the solid wound dressing. This classification does not include solid wound dressings containing a medically important antimicrobial as defined in the special controls.