BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Newa Skin Therapy System

    Reg #: 3010761224 · FEI: 3010761224 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ENDYMED MEDICAL INC.
    Registration Number
    3010761224
    FEI Number
    3010761224
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    4400 Route 9 South
    City
    East Freehold
    State
    NJ
    ZIP
    07728
    Country
    US

    Regulatory Submissions

    510(k) Number
    K130793

    Owner / Operator

    Firm Name
    EndyMed Medical Inc.
    Operator Number
    10046035
    Address
    4400 Route 9 South
    City
    East Freehold
    State
    NJ
    Postal Code
    07728
    Country
    US
    Correspondent
    Yoram Levy

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    Newa Skin Therapy System Newa, Newa Plus

    Establishment Types

    Repack or Relabel Medical Device