BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    ENRAF-NONIUS B.V.

    Reg #: 9612147 · FEI: 3002806913 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    38
    Establishment Types
    4
    Classifications
    12

    Registration Details

    Registration Name
    ENRAF-NONIUS B.V.
    Registration Number
    9612147
    FEI Number
    3002806913
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    127, VARESEWEG, -
    City
    ROTTERDAM Zuid-Holland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K060395

    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
    Powered Laser Surgical Instrument GEX
    Stimulator, Muscle, Powered IPF
    Table, Powered INQ
    Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
    Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat IMG
    Lamp, Infrared, Therapeutic Heating ILY
    Exerciser, Powered BXB
    Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat IMI
    Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat IMJ
    Massager, Therapeutic, Electric ISA
    Equipment, Traction, Powered ITH
    Massager, Vacuum, Radio Frequency Induced Heat PBX

    Proprietary Names

    CryoOne Compact-II ManuXelect Manumed Manumed ST ManuMax Zimmer aXionXelect Omniversa Sonopuls 494 Sonopuls 492 Endolaser HP OptonPro 25W EN-Dynamic Fly EN-Dynamic Rowing EN-Dynamic Back Trainer EN-Dynamic Total Hip EN-Dynamic Squat EN-Dynamic Abdominal Trainer EN-Dynamic Seated Leg Press EN-Dynamic Abduction EN-Dynamic Leg Extension EN-Dynamic Rotator EN-Dynamic Pull Down EN-Dynamic Seated Leg Curl EN-Dynamic Adduction EN-Dynamic Chest Press EN-Dynamic Shoulder Press EN-Dynamic Triceps Dips Sono2 Sonopuls 190 Endolaser 120 Curapuls 670 Endopuls FSWT EndoPuls 811 Dynatron SmarTRAC Eltrac 471 Tecarpuls-II

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198