BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    Glatopaject

    Reg #: 3027031650 · FEI: 3027031650 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Novartis Pharmaceutical Manufacturing GmbH
    Registration Number
    3027031650
    FEI Number
    3027031650
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Biochemiestrasse 10
    City
    Langkampfen Tirol
    Country
    AT

    Regulatory Submissions

    510(k) Number
    K124026

    Owner / Operator

    Firm Name
    Novartis Pharmaceuticals Corporation
    Operator Number
    10028011
    Address
    One Health Plaza
    City
    East Hanover
    State
    NJ
    Postal Code
    07936
    Country
    US
    Correspondent
    Karen Costa

    US Agent

    Business Name
    NOVARTIS PHARMACEUTICALS CORPORATION
    Contact Name
    Karen Costa
    Address
    One Health Plaza
    City
    East Hanover
    State
    NJ
    ZIP
    07936
    Country
    US
    Email
    [email protected]
    Phone
    862 3083443

    Products

    Device Name Product Code
    Introducer, Syringe Needle KZH

    Proprietary Names

    Glatopaject

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)