BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    INFINITT HEALTHCARE CO., LTD.

    Reg #: 3003989064 · FEI: 3003989064 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    25
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    INFINITT HEALTHCARE CO., LTD.
    Registration Number
    3003989064
    FEI Number
    3003989064
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    12F Daerung Post Tower III, 27 Digital-ro 34-gil, Guro-gu, Seoul, 08378, South Korea
    City
    SEOUL
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K102684

    Owner / Operator

    Firm Name
    INFINITT Healthcare Co., Ltd.
    Operator Number
    9055477
    Address
    12F Daerung Post Tower III, 182-4, Guro-Dong, Guro-Gu
    City
    SEOUL
    State
    KR-NOTA
    Postal Code
    08378
    Country
    KR
    Correspondent
    JinJun - Kim

    US Agent

    Business Name
    David Smarro
    Contact Name
    David Smarro
    Address
    755 Memorial Parkway, Suite 304
    City
    Phillipsburg
    State
    NJ
    ZIP
    08865
    Country
    US
    Email
    [email protected]
    Phone
    908 3876960 ext. 111

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    System, Digital Image Communications, Radiological LMD
    Digital Pathology Image Viewing And Management Software QKQ

    Proprietary Names

    XELIS DENTAL Xelis Cardiac Xelis Fusion INFINITT ULite ULite STARPACS Dental INFINITT RT Mobile INFINITT Cardiology PACS INFINITT Cardiology STARPACS Orthopedics System STARPACS INFINITT RT PACS Xelis 3D INFINITT MAMMO 7 INFINITT G7 PACS INFINITT PACS 7 INFINITT DPS Xelis Dental 2 INFINITT Mammo INFINITT PACS INFINITT G3 RapidiaColon System Reformat Gateway XELIS Colon XELIS

    Establishment Types

    Manufacture Medical Device