BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    Haemonetics Mexico Manufacturing S. de R.L. de C.V.

    Reg #: 9617787 · FEI: 3003327833 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    Haemonetics Mexico Manufacturing S. de R.L. de C.V.
    Registration Number
    9617787
    FEI Number
    3003327833
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Calle Colinas No. 11731 Secc. Colinas, Parque Industrial el Florido
    City
    TIJUANA, B.C. Mexico
    Country
    MX

    Regulatory Submissions

    510(k) Number
    BK870026

    Owner / Operator

    Firm Name
    Haemonetics Corporation
    Operator Number
    1219343
    Address
    125 Summer St
    City
    Boston
    State
    MA
    Postal Code
    02110
    Country
    US
    Correspondent
    Julie A Ryan

    US Agent

    Business Name
    HAEMONETICS CORPORATION
    Contact Name
    Julie A Ryan
    Address
    125 Summer St
    City
    Boston
    State
    MA
    ZIP
    02110
    Country
    US
    Email
    [email protected]
    Phone
    781 6900575

    Products

    Device Name Product Code
    Separator, Automated, Blood Cell, Diagnostic GKT
    Separator, Automated, Blood Cell And Plasma, Therapeutic LKN
    Apparatus, Autotransfusion CAC
    Pump, Portable, Aspiration (Manual Or Powered) BTA
    Pump, Infusion FRN
    System, Processing For Frozen Blood KSW
    Container, Empty, For Collection & Processing Of Blood & Blood Components KSR

    Proprietary Names

    PCS2 NexSys PCS Red Blood Cells & Plasma Disposable Set w/RBC LR Filter THERAPEUTIC PLASMA EXCHANGE SET Cell Saver 5, Cell Saver 5+ Cell Saver Elite MCS+8150 Apheresis System SmartSuction Harmony Cell Saver 5 Cymbal R.I.S. Haemonetics Model 215 Automated Glycerolization/Deglycerolization and Cell Washing System ACP215 PCS2, PCS 300, NexSys PCS MCS+9000, SDP revision E software, 994CF-CPP series disposable sets

    Establishment Types

    Manufacture Medical Device