BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    NEW ERA MEDICARE SDN BHD

    Reg #: 3021591322 · FEI: 3021591322 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    NEW ERA MEDICARE SDN BHD
    Registration Number
    3021591322
    FEI Number
    3021591322
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    PT 2621-2624, Batu 8, Jalan Changkat Jong
    City
    Teluk Intan Perak
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K241909

    Owner / Operator

    Firm Name
    New Era Medicare Sdn Bhd
    Operator Number
    10084255
    Address
    PT 2621-2624, Batu 8, Jalan Changkat Jong
    City
    Teluk Intan
    State
    Perak
    Postal Code
    36000
    Country
    MY

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs OPJ
    Fentanyl And Other Opioid Protection Glove QDO
    Medical Glove, Specialty LZC
    Polymer Patient Examination Glove LZA

    Establishment Types

    Repack or Relabel Medical Device