BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Face Mask; Surgical Mask; Azer Surgical Mask; Azer Surgical Mask with Eye Shield; Azer Tie-Back Surgical Mask

    Reg #: 3009963993 · FEI: 3009963993 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    AZER SCIENTIFIC, INC.
    Registration Number
    3009963993
    FEI Number
    3009963993
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    701 Hemlock Rd
    City
    Morgantown
    State
    PA
    ZIP
    19543
    Country
    US

    Regulatory Submissions

    510(k) Number
    K123787

    Owner / Operator

    Firm Name
    Azer Scientific, Inc.
    Operator Number
    9062234
    Address
    701 Hemlock Road, --
    City
    Morgantown
    State
    PA
    Postal Code
    19543
    Country
    US
    Correspondent
    Flip - Britton

    Products

    Device Name Product Code
    Mask, Surgical FXX

    Proprietary Names

    Face Mask; Surgical Mask; Azer Surgical Mask; Azer Surgical Mask with Eye Shield; Azer Tie-Back Surgical Mask

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device