BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Chocolate Bite; Clear Bite; Mega Bite; Vanilla Bite

    Reg #: 3010419931 · FEI: 3010419931 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SIGNA MEDICAL, INC.
    Registration Number
    3010419931
    FEI Number
    3010419931
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    100 West Broadway, Suite 7Y
    City
    Long Beach
    State
    NY
    ZIP
    11561
    Country
    US

    Regulatory Submissions

    510(k) Number
    K030776

    Owner / Operator

    Firm Name
    Signa Medical, Inc.
    Operator Number
    10045410
    Address
    100 West Broadway, Suite 7Y
    City
    Long Beach
    State
    NY
    Postal Code
    11561
    Country
    US
    Correspondent
    Alex Kleiman

    Products

    Device Name Product Code
    Material, Impression ELW

    Proprietary Names

    Chocolate Bite; Clear Bite; Mega Bite; Vanilla Bite

    Establishment Types

    Repack or Relabel Medical Device