BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    HI MEDICAL CO., LTD.

    Reg #: 3012502601 · FEI: 3012502601 · Expires 2026
    View on FDA
    Products
    36
    Proprietary Names
    16
    Establishment Types
    1
    Classifications
    36

    Registration Details

    Registration Name
    HI MEDICAL CO., LTD.
    Registration Number
    3012502601
    FEI Number
    3012502601
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    B-2005, 583, YANGCHEON-RO , GANGSEO-GU,
    City
    SEOUL
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K041071

    Owner / Operator

    Firm Name
    HI MEDICAL CO., LTD.
    Operator Number
    10052106
    Address
    B-2005, 583, YANGCHEON-RO , GANGSEO-GU,
    City
    SEOUL
    State
    KR-11
    Postal Code
    07547
    Country
    KR
    Correspondent
    SEONG IL CHOI

    US Agent

    Business Name
    SKY EAGLE LOGISTICS, INC.
    Contact Name
    MYEONG HO HA
    Address
    247 E Redondo Beach Blvd
    City
    Gardena
    State
    CA
    ZIP
    90248
    Country
    US
    Email
    [email protected]
    Phone
    310 8633700

    Products

    Device Name Product Code
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Cement, Dental EMA
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Tape And Bandage, Adhesive KGX
    Holder, Film, X-Ray EGZ
    Agent, Tooth Bonding, Resin KLE
    Needle, Hypodermic, Single Lumen FMI
    Accessories, Implant, Dental, Endosseous NDP
    Liner, Cavity, Calcium Hydroxide EJK
    Cement, Stomal Appliance, Ostomy EZR
    Dressing, Wound, Drug FRO
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    Bone Cement LOD
    Dressing, Wound, Hydrogel Without Drug And/Or Biologic NAE
    Material, Impression ELW
    Dressing, Wound And Burn, Occlusive MGP
    Syringe, Restorative And Impression Material EID
    Dressing, Wound, Occlusive NAD
    Dressing, Wound, Hydrophilic NAC
    Irrigator, Ostomy EXD
    Protector, Ostomy EXE
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Suture, Nonabsorbable, Synthetic, Polypropylene GAW
    Suture, Absorbable, Natural GAL
    Suture, Nonabsorbable, Synthetic, Polyamide GAR
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Suture, Nonabsorbable, Silk GAP
    Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile GAQ
    Tube Tracheostomy And Tube Cuff JOH
    Suture, Surgical, Absorbable, Polydioxanone NEW
    Mask, Surgical FXX
    Protector, Skin Pressure FMP
    Indicator, Physical/Chemical Sterilization Process JOJ
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Automated External Defibrillators (Non-Wearable) MKJ
    Suture, Absorbable, Synthetic GAN

    Proprietary Names

    BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE GC 3M Nexcare 3M ESPE Dentsply BD BD Microtainer MAP Microtube for Automated Process Denstply 3M Convatec Kulzer Leukotape, Cover-roll, Haypafix ETHICON Medtronic J&J ETHICON Smith&Nephew

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device