BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    HARLEIGH (MALAYSIA) SDN. BHD.

    Reg #: 3015430860 · FEI: 3015430860 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    3

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    Registration Details

    Registration Name
    HARLEIGH (MALAYSIA) SDN. BHD.
    Registration Number
    3015430860
    FEI Number
    3015430860
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No 4, Jalan Tahana,Tampoi Industrial Estate
    City
    Johor Bahru
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K123994
    PMA Number
    P010019

    Owner / Operator

    Firm Name
    Harleigh (Malaysia) Sdn. Bhd.
    Operator Number
    10060965
    Address
    No 4, Jalan Tahana,Tampoi Industrial Estate
    City
    Johor Bahru
    State
    MY-01
    Postal Code
    80350
    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
    Lens, Contact, (Disposable) MVN
    Lenses, Soft Contact, Daily Wear LPL
    Lenses, Soft Contact, Extended Wear LPM

    Establishment Types

    Repack or Relabel Medical Device