BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    PSC2 Alta

    Reg #: 3004832480 · FEI: 3004832480 · Expires 2025
    View on FDA
    Products
    10
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    10

    Registration Details

    Registration Name
    SUPERCOMAL MEDICAL PRODUCTS, SDN BHD
    Registration Number
    3004832480
    FEI Number
    3004832480
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    LOT 171,JALAN PKNK 3/8,KAWASAN, PERUSAHAAN, SUNGAI PETANI
    City
    SUNGAI PETANI Kedah
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K242451

    Owner / Operator

    Firm Name
    SUPERCOMAL MEDICAL PRODUCTS, SDN BHD
    Operator Number
    9065891
    Address
    LOT 172,JALAN PKNK 3/8,KAWASAN, PERUSAHAAN, SUNGAI PETANI
    City
    SUNGAI PETANI, KEDAH D.A.
    State
    MY-NOTA
    Postal Code
    08000
    Country
    MY

    US Agent

    Business Name
    BENTLEY BIOMEDICAL CONSULTING, LLC.
    Contact Name
    SHEPARD BENTLEY
    Address
    29461 TROON STREET
    City
    Laguna Beach
    State
    CA
    ZIP
    92677
    Country
    US
    Email
    [email protected]
    Phone
    949 4954274

    Products

    Device Name Product Code
    Cerebral Oximeter QEM
    Catheter, Oximeter, Fiber-Optic DQE
    Adjunctive Open Loop Fluid Therapy Recommender QMS
    Plethysmograph, Impedance DSB
    Catheter, Flow Directed DYG
    Continuous Measurement Thermometer FLL
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Medium-Term Adjunctive Predictive Cardiovascular Indicator QNL
    Adjunctive Predictive Cardiovascular Indicator QAQ
    Oximeter, Tissue Saturation MUD

    Proprietary Names

    PSC2 Alta HEMAPSC200 HEMA70CC2 Alta Swan

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)