BEUDAMED
    FDA Registration Active 🇫🇷 France

    BALLOON FOR ECHOENDOSCOPY

    Reg #: 3000296634 · FEI: 3000296634 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PRINCE MEDICAL SAS
    Registration Number
    3000296634
    FEI Number
    3000296634
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    64 RUE GUTENBERG
    City
    ERCUIS Oise
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K180731

    Owner / Operator

    Firm Name
    OMERIN CABLES SAS
    Operator Number
    9091979
    Address
    Zone industrielle 63600 Ambert - France
    City
    AMBERT
    State
    Auvergne-Rhone-Alpes
    Postal Code
    63600
    Country
    FR

    US Agent

    Business Name
    OMERIN
    Contact Name
    Michael Stark
    Address
    95 RESEARCH PARKWAY, 95 RESEARCH PARKWAY
    City
    Meriden
    State
    CT
    ZIP
    06450
    Country
    US
    Email
    [email protected]
    Phone
    203 2372297

    Products

    Device Name Product Code
    Endoscopic Ultrasound System, Gastroenterology-Urology ODG

    Proprietary Names

    BALLOON FOR ECHOENDOSCOPY

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)