BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CardiaMend

    Reg #: 3025316685 · FEI: 3025316685 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HELIOS BIOMEDICAL INC.
    Registration Number
    3025316685
    FEI Number
    3025316685
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8 Mercer Rd
    City
    Natick
    State
    MA
    ZIP
    01760
    Country
    US

    Regulatory Submissions

    510(k) Number
    K210331

    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

    Proprietary Names

    CardiaMend

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)