BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    GrindCare System

    Reg #: 3010354240 · FEI: 3010354240 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ESCATEC MEDICAL SDN BHD
    Registration Number
    3010354240
    FEI Number
    3010354240
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Plot 107, Jalan Hilir Sungai Keluang 5, Bayan Lepas Industrial Park Phase 4
    City
    Bayan Lepas Pulau Pinang
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K163448

    Owner / Operator

    Firm Name
    ESCATEC Medical Sdn Bhd
    Operator Number
    10047318
    Address
    Plot 107 Jalan Hilir Sungai Keluang 5, Bayan Lepas IndustrialPark Phase 4
    City
    Bayan Lepas
    State
    Pulau Pinang
    Postal Code
    11900
    Country
    MY
    Correspondent
    Mindy McCann

    US Agent

    Business Name
    QServe Group US Inc.
    Contact Name
    Mindy McCann
    Address
    350 S Main Street, Suite 309
    City
    Doylestown
    State
    PA
    ZIP
    18901
    Country
    US
    Email
    [email protected]
    Phone
    424 2718169

    Products

    Device Name Product Code
    Device, Biofeedback HCC

    Proprietary Names

    GrindCare System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)