BEUDAMED
    FDA Registration Active 🇹🇭 Thailand

    EnCor MRI Introducer Set

    Reg #: 9680340 · FEI: 1000434163 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    INFUS MEDICAL (THAILAND) CO., LTD.
    Registration Number
    9680340
    FEI Number
    1000434163
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    706 MOO 4, Bangpoo Industrial Estate, I-EA-T Free Zone, Tambon Preaksa
    City
    Amphoe Muang Samutprakarn Samut Prakan
    Country
    TH

    Regulatory Submissions

    510(k) Number
    K042098

    Owner / Operator

    Firm Name
    Infus Medical (Thailand) Co., Ltd.
    Operator Number
    9008323
    Address
    706 Moo 4, Bangpoo Industrial Estate,, I-EA-T Free Zone, T. Preaksa, A. Muang
    City
    Samutprakarn
    State
    TH-NOTA
    Postal Code
    10280
    Country
    TH
    Correspondent
    Patcharin - Vinitwatanakhun

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    EnCor MRI Introducer Set

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)