FDA.reportPublic FDA data

HELIOS BIOMEDICAL INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30253166853025316685HELIOS BIOMEDICAL INC.1N2026-01-018 Mercer Rd Natick MA US 01760

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3107461694780961K250420Helios Dura Regeneration MatrixGXQ2025-05-14
3107461936770329K250397Helios Dermal ScaffoldKGN2025-08-15
3107461737040855

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KGN12025-08-15
GXQ12025-05-14