BEUDAMED
    FDA Registration Active 🇫🇷 France

    ROSA ONE Brain application

    Reg #: 3009185973 · FEI: 3009185973 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    MEDTECH SAS
    Registration Number
    3009185973
    FEI Number
    3009185973
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    432 rue du Rajol
    City
    MAUGUIO Occitanie
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K214065

    Owner / Operator

    Firm Name
    MEDTECH S.A.S
    Operator Number
    10034131
    Address
    432 rue Rajol
    City
    MAUGUIO
    State
    Herault
    Postal Code
    34130
    Country
    FR
    Correspondent
    Paul HARDY

    US Agent

    Business Name
    Zimmer Biomet
    Contact Name
    Holly Seppanen
    Address
    1800 West Center Street
    City
    Warsaw
    State
    IN
    ZIP
    46580
    Country
    US
    Email
    [email protected]
    Phone
    952 8470494

    Products

    Device Name Product Code
    Neurological Stereotaxic Instrument HAW

    Proprietary Names

    ROSA ONE Brain application

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device