BEUDAMED
    FDA Registration Active 🇻🇳 Vietnam

    ANKLE BRACE

    Reg #: 3006400320 · FEI: 3006400320 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    HAMECO HY CO., LTD
    Registration Number
    3006400320
    FEI Number
    3006400320
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    CHI TRUNG HAMLET, TAN QUANG COMMUNE, VAN LAM DISTRICT
    City
    HUNG YEN PROVINCE
    Country
    VN

    Regulatory Submissions

    510(k) Number
    K810443

    Owner / Operator

    Firm Name
    HAMECO., JSC
    Operator Number
    9096901
    Address
    17 Pho Duc Chinh Str., Ba Dinh Dist.
    City
    HA NOI
    State
    VN-NOTA
    Postal Code
    100000
    Country
    VN
    Correspondent
    LE TAT CO

    Products

    Device Name Product Code
    Orthosis, Limb Brace IQI

    Proprietary Names

    ANKLE BRACE LIMB ORTHOSIS RIB BELT CPM Pads

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device