BEUDAMED
    FDA Registration Active 🇻🇳 Vietnam

    HAMECO HY CO., LTD

    Reg #: 3006400320 · FEI: 3006400320 · Expires 2026
    View on FDA
    Products
    31
    Proprietary Names
    33
    Establishment Types
    3
    Classifications
    31

    Registration Details

    Registration Name
    HAMECO HY CO., LTD
    Registration Number
    3006400320
    FEI Number
    3006400320
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    CHI TRUNG HAMLET, NHU QUYNH COMMUNE
    City
    HUNG YEN PROVINCE
    Country
    VN

    Regulatory Submissions

    510(k) Number
    K823808

    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, Lumbar IQE
    Bedding, Disposable, Medical KME
    Pediatric Position Holder PRN
    Tips And Pads, Cane, Crutch And Walker INP
    Protector, Skin Pressure FMP
    Aid, Transfer IKX
    Pack, Hot Or Cold, Reusable IME
    Binder, Medical, Therapeutic MDR
    Support, Hernia EXN
    Sling, Arm ILI
    Joint, Ankle, External Brace ITW
    Orthosis, Truncal/Orthosis, Limb MRI
    Bandage, Elastic FQM
    Accessories, Wheelchair KNO
    Stirrup, External Brace Component ITC
    Joint, Knee, External Brace ITQ
    Gown, Examination FME
    Exerciser, Powered BXB
    Orthosis, Limb Brace IQI
    Band Or Belt, Pelvic Support ISR
    Components, Exercise IOD
    Gauze / Sponge,Nonresorbable For External Use NAB
    Orthosis, Abdominal KTD
    Cushion, Wheelchair IMP
    Orthosis, Cervical IQK
    Adaptor, Hygiene ILS
    Restraint, Protective FMQ
    Splint, Hand, And Components ILH
    Support, Patient Position CCX
    Tape, Measuring, Rulers And Calipers FTY
    Non-Surgical Gown OEA

    Proprietary Names

    Back support with suspenders max soos 3 Disposable Armboard Cover CIRCUMSTRAINT BOARD STRAPS Crutch Pillow PILLOW,COMFORT PLUS ELBOW AND FOOT,PR LIFTER,LEG,BLACK,40" Packs Binder, Medical, Therapeutic Hernia belt SHOULDER IMMOBILIZER Ankle Support ORBE Finger Sleeves CUSHION,WHEELCHAIR, GEL FOAM CUSHION Stirrup Strap KNEE IMMOBILIZER Examination Gown cpm pad LIMB ORTHOSIS RIB BELT ANKLE BRACE CPM Pads Maternity belt Surgical Sponge Sticks Tri-Panel Abdominal Binders Cushion Gel Padded Elevated Toilet Seat UNIVERSAL STRAP WRIST SPLINT Knee and Body Strap Armboard Strap Tape measurement gown

    Establishment Types

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