HELIOS BIOMEDICAL INC.
Matched from indexed company URL: Helios Biomedical, Inc.
FDA Registration(s)#
Registration, FEI, Name table| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|
| 3025316685 | 3025316685 | HELIOS BIOMEDICAL INC. | 1 | N | 2026-01-01 | 8 Mercer Rd Natick MA US 01760 |
Registered Device Listings#
Registration key, Listing key, Premarket submission table| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|
| 310746 | 1694780961 | K250420 | Helios Dura Regeneration Matrix | GXQ | 2025-05-14 |
| 310746 | 1936770329 | K250397 | Helios Dermal Scaffold | KGN | 2025-08-15 |
| 310746 | 1737040855 | | | | |
Product Codes Associated With Registrations#
Product code, Registration listing records, Latest decision table| Product code | Registration listing records | Latest decision |
|---|
| KGN | 1 | 2025-08-15 |
| GXQ | 1 | 2025-05-14 |