BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HELIOS BIOMEDICAL INC.

    Reg #: 3025316685 · FEI: 3025316685 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    HELIOS BIOMEDICAL INC.
    Registration Number
    3025316685
    FEI Number
    3025316685
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    8 Mercer Rd
    City
    Natick
    State
    MA
    ZIP
    01760
    Country
    US

    Regulatory Submissions

    510(k) Number
    K250397

    Owner / Operator

    Firm Name
    Helios Biomedical Inc.
    Operator Number
    10086401
    Address
    8 Mercer Rd
    City
    Natick
    State
    MA
    Postal Code
    01760
    Country
    US
    Correspondent
    Susan Reilly

    Products

    Device Name Product Code
    Intracardiac Patch Or Pledget, Biologically Derived PSQ
    Wound Dressing With Animal-Derived Material(S) KGN
    Dura Substitute GXQ

    Proprietary Names

    CardiaMend Helios Dermal Scaffold Helios Dura Regeneration Matrix

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device