BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    H&ABYZ

    Reg #: 3016674851 · FEI: 3016674851 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    16
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    H&ABYZ
    Registration Number
    3016674851
    FEI Number
    3016674851
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2-dong, 41-16 Cheoinseong-ro, Namsa-eup, Cheoin-gu, Yongin-si, Gyeonggi-do, 17118, Republic of Korea
    City
    Yongin-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K203188

    Owner / Operator

    Firm Name
    H&abyz
    Operator Number
    10062737
    Address
    2-dong, 41-16 Cheoinseong-ro, Namsa-eup, Cheoin-gu, Yongin-si, Gyeonggi-do, 17118, Republic of Korea
    City
    Yongin-si
    State
    Gyeonggi
    Postal Code
    17118
    Country
    KR

    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
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Stationary KPR
    System, X-Ray, Mobile IZL

    Proprietary Names

    GR40CW S4335-WV GC85A GM85 A1717MCW A1417MCW F1417MCW S4335-W XGEO GR40CW S4343-W S3025-W GR40CWC GR40CWD HnX-P1 HnX-PB HAD1717MC

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device