Amferia Wound Dressing— 510(k) DEN250006
UnknownAmferia AB
FDA 510(k) clearance DEN250006 for Amferia Wound Dressing, Unknown on 2026-02-06. Applicant: Amferia AB. Device class: 2.
Summary
Amferia AB's Amferia Wound Dressing is filed under product code SHA (Solid Wound Dressing With Permanently Bound Antimicrobial Agent). The record doesn't describe the dressing beyond its name and that code name.
Class II, 21 CFR 878.4013. General, Plastic Surgery is both the classification panel and the review panel. The record lists the submission type as Direct.
Amferia filed from Molndal, Sweden. The decision date came 340 calendar days after the received date (March 3, 2025 to February 6, 2026).
Clearance details
- Applicant
- Amferia AB
- Product code
- Product code SHA
- Device class
- Class 2
- Regulation
- 21 CFR 878.4013
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Molndal, SE
Data sourced from openFDA. This site is unofficial and independent of the FDA.