BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    GUNZE MEDICAL LIMITED

    Reg #: 3027419979 · FEI: 3027419979 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    GUNZE MEDICAL LIMITED
    Registration Number
    3027419979
    FEI Number
    3027419979
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5F, JRE Dojima Tower, 2-4-27, Dojima, Kita-ku
    City
    Osaka
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K221487

    Owner / Operator

    Firm Name
    GUNZE MEDICAL LIMITED
    Operator Number
    10088147
    Address
    15F, Tokyo Shiodome Bldg., 1-9-1, Higashi-Shinbashi,
    City
    Minato-ku
    State
    Tokyo
    Postal Code
    1057315
    Country
    JP
    Correspondent
    Aya Mikami

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Mesh, Surgical, Absorbable, Staple Line Reinforcement OXC
    Wound Dressing With Animal-Derived Material(S) KGN

    Proprietary Names

    NEOVEIL Staple Line Reinforcement TheraGenesis Non-Meshed Bilayer Wound Matrix TheraGenesis Meshed Bilayer Wound Matrix NEOVEIL Sheet Type Suture and Staple Line Reinforcement Material; NEOVEIL Tube Type Staple Line Reinforcement Material

    Establishment Types

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