BEUDAMED
    FDA Registration Active 🇫🇷 France

    MacoMix HM20 and Hemolog 6

    Reg #: 3004404323 · FEI: 3004404323 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    MACO PHARMA
    Registration Number
    3004404323
    FEI Number
    3004404323
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    233 RUE LORTHIOIS, --
    City
    MOUVAUX Hauts-de-France
    Country
    FR

    Regulatory Submissions

    510(k) Number
    BK160095

    Owner / Operator

    Firm Name
    MACO PHARMA
    Operator Number
    9067788
    Address
    233 RUE LORTHIOIS, --
    City
    MOUVAUX
    State
    Hauts-de-France
    Postal Code
    59420
    Country
    FR

    US Agent

    Business Name
    MACO PHARMA
    Contact Name
    Tiffiney Teo
    Address
    3075 Breckinridge Blvd Ste 405
    City
    Duluth
    State
    GA
    ZIP
    30096
    Country
    US
    Email
    [email protected]
    Phone
    770 2706867

    Products

    Device Name Product Code
    Device, Mixing And Weighing, Semi-Automated MYJ

    Proprietary Names

    MacoMix HM20 and Hemolog 6

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device