BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    FlashHeal 2

    Reg #: 3035358221 · FEI: 3035358221 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Inwound ApS
    Registration Number
    3035358221
    FEI Number
    3035358221
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Herlufsholmvej 37
    City
    Vanloese Hovedstaden
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K233077

    Owner / Operator

    Firm Name
    Inwound ApS
    Operator Number
    10093297
    Address
    Herlufsholmvej 37
    City
    Vanløse
    State
    Hovedstaden
    Postal Code
    2720
    Country
    DK
    Correspondent
    Guilherme Fiorezi

    US Agent

    Business Name
    NexGen Health Group Inc.
    Contact Name
    Sung Kwon
    Address
    13925 City Center Dr Ste 200
    City
    Chino Hills
    State
    CA
    ZIP
    91709
    Country
    US
    Email
    [email protected]
    Phone
    909 2298249

    Products

    Device Name Product Code
    Lamp, Infrared, Therapeutic Heating ILY
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    FlashHeal 2

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device