BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    BIONIT LABS S.R.L.

    Reg #: 3018070844 · FEI: 3018070844 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    BIONIT LABS S.R.L.
    Registration Number
    3018070844
    FEI Number
    3018070844
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Via Cracovia, 1
    City
    Soleto Lecce
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K242326

    Owner / Operator

    Firm Name
    BionIT Labs S.r.l.
    Operator Number
    10080803
    Address
    Via Cracovia, 1
    City
    Soleto
    State
    Lecce
    Postal Code
    73010
    Country
    IT
    Correspondent
    Matteo Aventaggiato

    US Agent

    Business Name
    MACLIN POWER, INC.
    Contact Name
    Christian Costantini
    Address
    1465 Nw 97th Avenue West
    City
    Miami
    State
    FL
    ZIP
    33172
    Country
    US
    Email
    [email protected]
    Phone
    305 5910181

    Products

    Device Name Product Code
    Device, Skin Potential Measurement HCJ
    Hand, External Limb Component, Powered IQZ
    Electrode, Cutaneous GXY

    Proprietary Names

    Myo Unit Wave Electrode Remote Wave Electrode Adam's Hand Adam's Skin ThunderCell Battery Adam's Hand - Trial/Loaner

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198