BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    The Circadia C200 System

    Reg #: 3017760831 · FEI: 3017760831 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Hi-P ELECTRONICS (MALAYSIA) SDN. BHD.
    Registration Number
    3017760831
    FEI Number
    3017760831
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.50,(Lot 1229) Lorong Perusahaan 2A, Kawasan Perusahaan Kulim
    City
    Kulim Kedah
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K234003

    Owner / Operator

    Firm Name
    HI-P ELECTRONICS (MALAYSIA) SDN. BHD.
    Operator Number
    10079713
    Address
    No.50,(Lot 1229) Lorong Perusahaan 2A,, Kawasan Perusahaan Kulim, 09000 Kulim, Kedah Darul Aman, Malaysia.
    City
    Kulim
    State
    Kedah
    Postal Code
    09000
    Country
    MY
    Correspondent
    NURAZRITA ZAKARIA

    Products

    Device Name Product Code
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Monitor, Breathing Frequency BZQ

    Proprietary Names

    The Circadia C200 System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)