BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SurFuse

    Reg #: 3010376334 · FEI: 3010501626 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    GEV Co., Ltd.
    Registration Number
    3010376334
    FEI Number
    3010501626
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    37-10, Maengdongsandan-ro, Maengdong-myeon
    City
    Eumseong-gun Chungbuk
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K113728

    Owner / Operator

    Firm Name
    Seoul Radiology Service
    Operator Number
    10043696
    Address
    37-10, Maengdongsandan-ro, Maengdong-myeon
    City
    Eumseong-gun
    State
    Chungbuk
    Postal Code
    369-811
    Country
    KR
    Correspondent
    Cheol Ahn

    US Agent

    Business Name
    Hans Biomed USA, Inc.
    Contact Name
    Inhye Gwak
    Address
    140 Sylvan Ave Ste 301
    City
    Englewood Cliffs
    State
    NJ
    ZIP
    07632
    Country
    US
    Email
    [email protected]
    Phone
    201 2242333

    Products

    Device Name Product Code
    Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) MBP
    Filler, Bone Void, Calcium Compound MQV

    Proprietary Names

    SurFuse

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)