BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Ameda GLO Wearable Breast Pump (Model W8S)

    Reg #: 3031566471 · FEI: 3031566471 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TPH TECHNOLOGY MALAYSIA SDN. BHD.
    Registration Number
    3031566471
    FEI Number
    3031566471
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NO 2 (BLOCK C), JALAN RAWANG INDAH 1, TAMAN INDUSTRI RAWANG,48000 Rawang, Selangor
    City
    Rawang Selangor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K242850

    Owner / Operator

    Firm Name
    TPH TECHNOLOGY MALAYSIA SDN. BHD.
    Operator Number
    10090984
    Address
    NO 2 (BLOCK C), JALAN RAWANG INDAH 1, TAMAN INDUSTRI RAWANG,48000 Rawang, Selangor
    City
    Rawang
    State
    Selangor
    Postal Code
    48000
    Country
    MY
    Correspondent
    Peter Chen

    Products

    Device Name Product Code
    Pump, Breast, Powered HGX

    Proprietary Names

    Ameda GLO Wearable Breast Pump (Model W8S) Wearable Breast Pump (Model Comfort+) Wearable Breast Pump (Model W8) Wearable Breast Pump (Model APEX10) breast shell insert ardo melia wearable breast pump (Model melia)

    Establishment Types

    Repack or Relabel Medical Device