BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Sono2

    Reg #: 9612147 · FEI: 3002806913 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    ENRAF-NONIUS B.V.
    Registration Number
    9612147
    FEI Number
    3002806913
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    127, VARESEWEG, -
    City
    ROTTERDAM Zuid-Holland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K230472

    Owner / Operator

    Firm Name
    NEW COMPANY INVESTMENTS B.V.
    Operator Number
    9046108
    Address
    VARESEWEG 127, P.O.Box 12080, 3004 GB
    City
    ROTTERDAM
    State
    NL-NOTA
    Postal Code
    NL-3047AT
    Country
    NL
    Correspondent
    Anne-Marie VAN MAURIK

    US Agent

    Business Name
    Accelerated Care Plus
    Contact Name
    Lee Grasseschi
    Address
    1170 Trademark Dr Ste 104
    City
    Reno
    State
    NV
    ZIP
    89521
    Country
    US
    Email
    [email protected]
    Phone
    775 2231391

    Products

    Device Name Product Code
    Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat IMI

    Proprietary Names

    Sono2 Sonopuls 190

    Establishment Types

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