BEUDAMED
    FDA Registration Active 🇷🇴 Romania

    O'Neil Sterile Field Urinary Catheter

    Reg #: 9680787 · FEI: 3002826093 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HENNIG ENTERPRISES EUROPE S.R.L.
    Registration Number
    9680787
    FEI Number
    3002826093
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    B-DUL POITIERS 14
    City
    IASI
    Country
    RO

    Regulatory Submissions

    510(k) Number
    K993651

    Owner / Operator

    Firm Name
    HENNIG ENTERPRISES EUROPE S.R.L.
    Operator Number
    9011425
    Address
    B-DUL POITIER 14, --
    City
    IASI
    State
    RO-NOTA
    Postal Code
    700671
    Country
    RO

    US Agent

    Business Name
    Compliance Systems International, LLc.
    Contact Name
    Amanda SINGLETON
    Address
    39 Lockhart Circle
    City
    Buffalo
    State
    NY
    ZIP
    14228
    Country
    US
    Email
    [email protected]
    Phone
    716 4407364

    Products

    Device Name Product Code
    Catheter, Urethral GBM

    Proprietary Names

    O'Neil Sterile Field Urinary Catheter

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)