BEUDAMED
    FDA Registration Active 🇹🇭 Thailand

    Epic International (Thailand) Co., Ltd.

    Reg #: 3012429465 · FEI: 3012429465 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    22
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    Epic International (Thailand) Co., Ltd.
    Registration Number
    3012429465
    FEI Number
    3012429465
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Hemaraj Eastern Seaboard Industrial Estate, 500/73 Moo 2, Tasit
    City
    Pluak Daeng Rayong
    Country
    TH

    Regulatory Submissions

    510(k) Number
    K241988

    Owner / Operator

    Firm Name
    Epic Medical Pte Ltd
    Operator Number
    10051573
    Address
    105 Cecil Street #20-01, The Octagon
    City
    Singapore
    State
    Central Singapore
    Postal Code
    069534
    Country
    SG

    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
    Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System ONB
    Set, I.V. Fluid Transfer LHI
    Pump, Infusion, Elastomeric MEB
    Container, I.V. KPE
    Set, Administration, Intravascular FPA
    Dispenser, Liquid Medication KYX
    System/Device, Pharmacy Compounding NEP

    Proprietary Names

    ProSeal Closed System Bag Access SMARTeZ Pump McKesson EZ-FLOW SimplFusor MEDI-FLO eZSURE Empty Fluid Container Safety Subcutaneous Infusion Set ProSeal Injection Site Extended Male Luer Lock ProSeal Closed System Administration Set RxBot Peristaltic Pump Set, RxFill Tube Set eZSURE SMARTeZ Fluid Transfer Set SMARTeZ Pharmacy Filling Pump RxFill RxBot DOSI-FUSER ToxiSeal Vial Adaptor with External Flip Balloon ProSeal Injector Plus ProSeal Bag Spike with Additive Port ProSeal In Line Pump Set ProSeal CSTD

    Establishment Types

    Manufacture Medical Device