BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    PACEWELL ASIA SDN. BHD.

    Reg #: 3007791481 · FEI: 3007791481 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    PACEWELL ASIA SDN. BHD.
    Registration Number
    3007791481
    FEI Number
    3007791481
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 46-54 (PT9289, 9291, 9293-9297), Laluan Bemban, Kawasan Perindustrian Bemban
    City
    Batu Gajah Perak
    Country
    MY

    Owner / Operator

    Firm Name
    Pacewell Asia Sdn. Bhd.
    Operator Number
    10026951
    Address
    55A, Medan Ipoh 1A, Medan Ipoh Bistari
    City
    Ipoh
    State
    Perak
    Postal Code
    31400
    Country
    MY
    Correspondent
    CHAN YEW MEN

    US Agent

    Business Name
    T. Cunningham Consulting & Associates, LLC
    Contact Name
    TERRELL CUNNINGHAM
    Address
    12812 Meadowbrook Ln
    City
    Waldorf
    State
    MD
    ZIP
    20601
    Country
    US
    Email
    [email protected]
    Phone
    301 5359600

    Products

    Device Name Product Code
    Latex Patient Examination Glove LYY
    Polymer Patient Examination Glove LZA
    Medical Glove, Specialty LZC

    Proprietary Names

    Comfort Powder Free Latex Examination Gloves with Protein Content Labelling Claim Powder Free Nitrile (Orange) Examination Gloves Powder Free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs Labeling Claim (Green) Latex, Examination Gloves, Polymer Coated, Powder-Free, Contains 50 Micrograms or Lessof total water extractable protein Powder Free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs Labeling Claim (Blue, White) Powder Free Nitrile (Blue and White) Examination Gloves Powder Free Nitrile (Black) Examination Gloves

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)