BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    Bulkamid Urethral Bulking System

    Reg #: 3005111102 · FEI: 3005111102 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CONTURA INTERNATIONAL A/S
    Registration Number
    3005111102
    FEI Number
    3005111102
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Sydmarken 23
    City
    Soeborg Hovedstaden
    Country
    DK

    Regulatory Submissions

    PMA Number
    P170023

    Owner / Operator

    Firm Name
    Contura International A/S
    Operator Number
    10062518
    Address
    Sydmarken 23
    City
    Soeborg
    State
    Hovedstaden
    Postal Code
    2860
    Country
    DK
    Correspondent
    Carina Moldow

    US Agent

    Business Name
    BOSTON SCIENTIFIC CORPORATION
    Contact Name
    Aaron Dunbar
    Address
    300 Boston Scientific Way
    City
    Marlborough
    State
    MA
    ZIP
    01752
    Country
    US
    Email
    [email protected]
    Phone
    651 3961414

    Products

    Device Name Product Code
    Agent, Bulking, Injectable For Gastro-Urology Use LNM

    Proprietary Names

    Bulkamid Urethral Bulking System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)