BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    Multiple

    Reg #: 3007064586 · FEI: 3007064586 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Acme Monaco Asia Pte. Ltd.
    Registration Number
    3007064586
    FEI Number
    3007064586
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1 Genting Link, No. 04-05/06 Perfect One
    City
    Singapore Central Singapore
    Country
    SG

    Regulatory Submissions

    510(k) Number
    K920884

    Owner / Operator

    Firm Name
    ACME-MONACO CORP.
    Operator Number
    1293141
    Address
    75 WINCHELL DR., --
    City
    New Britain
    State
    CT
    Postal Code
    06052
    Country
    US
    Correspondent
    REBECCA - KARABIN

    Products

    Device Name Product Code
    Wire, Guide, Catheter DQX

    Proprietary Names

    Multiple

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device