BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AERIN MEDICAL INC.

    Reg #: 3011625895 · FEI: 3011625895 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    9
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    AERIN MEDICAL INC.
    Registration Number
    3011625895
    FEI Number
    3011625895
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2565 Leghorn St.
    City
    Mountain View
    State
    CA
    ZIP
    94043
    Country
    US

    Regulatory Submissions

    510(k) Number
    K200300

    Owner / Operator

    Firm Name
    Aerin Medical Inc.
    Operator Number
    10050618
    Address
    2565 Leghorn St.
    City
    Mountain View
    State
    CA
    Postal Code
    94043
    Country
    US
    Correspondent
    Teri Feeley

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP

    Proprietary Names

    VivAer® Stylus InSeca ARC Stylus Aerin Console RhinAer™ Stylus RhinAer+ Stylus RhinAer Stylus Vivaer ARC Stylus Vivaer Stylus Reach Needle

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility