BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Gynemed Brush

    Reg #: 3008144100 · FEI: 3008144100 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    RESOLUTION BIOMEDICAL, INC.
    Registration Number
    3008144100
    FEI Number
    3008144100
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1342 Bell Ave, Suite 3K
    City
    Tustin
    State
    CA
    ZIP
    92780
    Country
    US

    Regulatory Submissions

    510(k) Number
    K081522

    Owner / Operator

    Firm Name
    Resolution Biomedical, Inc.
    Operator Number
    10031116
    Address
    1342 Bell Ave, STE 3K
    City
    Tustin
    State
    CA
    Postal Code
    92780
    Country
    US
    Correspondent
    Michael Friedl

    Products

    Device Name Product Code
    Spatula, Cervical, Cytological HHT

    Proprietary Names

    Gynemed Brush

    Establishment Types

    Reprocess Single-Use Device Repack or Relabel Medical Device Manufacture Medical Device