BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    BIOBEAT TECHNOLOGIES LTD

    Reg #: 3015455735 · FEI: 3015455735 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    5
    Establishment Types
    3
    Classifications
    6

    Registration Details

    Registration Name
    BIOBEAT TECHNOLOGIES LTD
    Registration Number
    3015455735
    FEI Number
    3015455735
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    10, Moshe Dayan
    City
    Petakh Tikva Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K222010

    Owner / Operator

    Firm Name
    Biobeat Technologies LTD
    Operator Number
    10082659
    Address
    10 Moshe Dayan Street
    City
    Petach Tikva
    State
    Central
    Postal Code
    4951810
    Country
    IL
    Correspondent
    Johanan May

    US Agent

    Business Name
    A. Stein Regulatory Affairs
    Contact Name
    Naphtali Deutsch
    Address
    9595 Collins Ave Apt 506
    City
    Surfside
    State
    FL
    ZIP
    33154
    Country
    US
    Email
    [email protected]
    Phone
    888 4433867

    Products

    Device Name Product Code
    Continuous Measurement Thermometer FLL
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Monitor, Breathing Frequency BZQ
    Oximeter DQA
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG

    Proprietary Names

    Biobeat Platform 2 BB613WP BB613 BB-613-BPM BB-613 WP

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device