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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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De Novo Number DEN250006
Device Name Amferia Wound Dressing
Requester
amferia ab
c/o az bioventurehub astra zeneca
pepparedsleden 1
molndal,  SE 43183
Contact anand rajasekharan
Classification Product Code
SHA
Date Received03/03/2025
Decision Date 02/06/2026
Decision granted (DENG)
Review Advisory Committee General & Plastic Surgery
Type Direct
Predetermined Change
Control Plan Authorized		 No
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