BEUDAMED
    FDA Registration Active 🇫🇷 France

    BIOSERENITY MEDICAL DEVICES GROUP

    Reg #: 3014027738 · FEI: 3014027738 · Expires 2026
    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
    2026
    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
    Pierre Emerich

    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

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198