BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    ReDS Wearable System (ReDS System)

    Reg #: 3011773282 · FEI: 3011773282 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SENSIBLE MEDICAL INNOVATIONS Ltd.
    Registration Number
    3011773282
    FEI Number
    3011773282
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Meir Ariel 6
    City
    Netanya Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K150095

    Owner / Operator

    Firm Name
    Sensible Medical Innovations Ltd.
    Operator Number
    10050447
    Address
    Physical address:Meir Ariel 6
    City
    Netanya
    State
    Central
    Postal Code
    4250364
    Country
    IL
    Correspondent
    Ronit Shaanan

    US Agent

    Business Name
    Sensible Medical Innovations Inc.
    Contact Name
    John DeChellis
    Address
    355 South Main Street, First Floor
    City
    Greenville
    State
    SC
    ZIP
    29601
    Country
    US
    Email
    [email protected]
    Phone
    727 5994163

    Products

    Device Name Product Code
    Plethysmograph, Impedance DSB

    Proprietary Names

    ReDS Wearable System (ReDS System)

    Establishment Types

    Manufacture Medical Device