BEUDAMED
    FDA Registration Active 🇫🇷 France

    IceCap Neonate

    Reg #: 3014027738 · FEI: 3014027738 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BIOSERENITY MEDICAL DEVICES GROUP
    Registration Number
    3014027738
    FEI Number
    3014027738
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6/8 rue Jean Antoine de Baif
    City
    PARIS CEDEX 13 Ile-de-France
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K243788

    Owner / Operator

    Firm Name
    BIOSERENITY MEDICAL DEVICES GROUP
    Operator Number
    10089585
    Address
    6/8 rue Jean Antoine de Baif
    City
    Paris
    State
    Ile-de-France
    Postal Code
    75013
    Country
    FR
    Correspondent
    Melanie Renaud-Samiri

    US Agent

    Business Name
    VCLS Inc.
    Contact Name
    Kathy Fischer
    Address
    50 Division Street, Suite 206
    City
    Somerville
    State
    NJ
    ZIP
    08876
    Country
    US
    Email
    [email protected]
    Phone
    908 7041691 ext. 213

    Products

    Device Name Product Code
    Electrode, Cutaneous GXY

    Proprietary Names

    IceCap Neonate IceCap 2

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device