BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    PCS2

    Reg #: 3011538588 · FEI: 3011538588 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Haemonetics Malaysia Sdn Bhd
    Registration Number
    3011538588
    FEI Number
    3011538588
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    PMT 727, Persiaran Cassia Selatan 1, Taman Perindustrian Batu Kawan,14100 Simpang Ampat
    City
    Penang Pulau Pinang
    Country
    MY

    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

    Proprietary Names

    PCS2 NexSys PCS

    Establishment Types

    Manufacture Medical Device