BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    CLARIPI INC.

    Reg #: 3015537315 · FEI: 3015537315 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    5
    Classifications
    4

    Registration Details

    Registration Name
    CLARIPI INC.
    Registration Number
    3015537315
    FEI Number
    3015537315
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    11 Ihwajang 1-gil, Jongro-gu
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K203785

    Owner / Operator

    Firm Name
    CLARIPI Inc.
    Operator Number
    10060777
    Address
    11 Ihwajang 1-gil, Jongro-gu
    City
    Seoul
    State
    KR-NOTA
    Postal Code
    03100
    Country
    KR
    Correspondent
    Hyun-Sook Park

    US Agent

    Business Name
    ClariPi USA Inc.
    Contact Name
    Harry Park
    Address
    1645 Park Creek CT
    City
    Rochester Hills
    State
    MI
    ZIP
    48309
    Country
    US
    Email
    [email protected]
    Phone
    248 9304204

    Products

    Device Name Product Code
    Automated Radiological Image Processing Software QIH
    System, Image Processing, Radiological LLZ
    System, Digital Image Communications, Radiological LMD
    System, X-Ray, Tomography, Computed JAK

    Proprietary Names

    ClariSigmam ClariCT.AI ClariPlatform ClariPulmo

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility Reprocess Single-Use Device