BEUDAMED
    FDA Registration Active 🇫🇷 France

    MACO PHARMA

    Reg #: 3004404323 · FEI: 3004404323 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    20
    Establishment Types
    4
    Classifications
    4

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    Registration Details

    Registration Name
    MACO PHARMA
    Registration Number
    3004404323
    FEI Number
    3004404323
    Status
    Active
    Expiry Year
    2026
    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
    Microfilter, Blood Transfusion CAK
    Device, Heat-Sealing KSD
    Supplies, Blood-Bank KSS

    Proprietary Names

    MacoMix HM20 and Hemolog 6 LCG2b with AS-1, AS-3 and AS-5 MACOSEAL PS2-AS MACOSEAL LIGHT SE160 9MPS2BRLAN: MacoPress Smart Smarter and DMS Ethernet Module - no breaker 9MPS2BIWIFI: MacoPress Smart Smarter and DMS WIFI Module - with breaker module for main press 9MPS2BRWIFI: MacoPress Smart Smarter and DMS WIFI Module - no breaker 9MPS2BILAN: MacoPress Smart Smarter and DMS Ethernet Module - with breaker module for main press 9MPSBRWIFI: MacoPress Smart and DMS WiFi Module - no breaker 9MPSBRLAN: MacoPress Smart and DMS Ethernet Module - no breaker 9MPSBIWIFI: MacoPress Smart and DMS WiFi Module - with breaker for main press 9MPSBILAN: MacoPress Smart and DMS Ethernet Module - with breaker for main press 9MPSBI485: MacoPress Smart and DMS RS485 Module - with breaker for main press 9MPSBR485: MacoPress Smart and DMS RS485 Module - no breaker VSL7000YD - Therapeutic Phlebotomy Bag VSE8004XD - Empty Bag 600 ml 6-way man VQE2001XD - 4 Empty Bags 300ML VSE3010XD - Empty Bag 300ML 6-Way Man VSL 7001PD - Therapeutic Phlebotomy Bag w/Needle

    Establishment Types

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