BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Earflo Company

    Reg #: 3043739646 · FEI: 3043739646 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

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    Registration Details

    Registration Name
    Earflo Company
    Registration Number
    3043739646
    FEI Number
    3043739646
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    203 Lothrop St, Suite 500
    City
    Pittsburgh
    State
    PA
    ZIP
    15213
    Country
    US

    Regulatory Submissions

    510(k) Number
    K252751

    Owner / Operator

    Firm Name
    Earflo Inc.
    Operator Number
    10095482
    Address
    848 Knoll Drive
    City
    San Carlos
    State
    CA
    Postal Code
    94070
    Country
    US
    Correspondent
    Intan Oldakowska

    Products

    Device Name Product Code
    Device, Inflation, Middle Ear MJV

    Proprietary Names

    Earflo EF001 Device

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility