BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    REGIUS Cassette

    Reg #: 3004485675 · FEI: 3004485675 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KONICA MINOLTA, INC.
    Registration Number
    3004485675
    FEI Number
    3004485675
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1 SAKURA-MACHI
    City
    HINO-SHI Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K092717

    Owner / Operator

    Firm Name
    KONICA MINOLTA, INC.
    Operator Number
    9009884
    Address
    1 Sakura-machi
    City
    Hino-shi
    State
    Tokyo
    Postal Code
    191-8511
    Country
    JP
    Correspondent
    Emi Yamaguchi

    US Agent

    Business Name
    Konica Minolta Healthcare Americas, Inc.
    Contact Name
    Jan Maniscalco
    Address
    411 Newark Pompton Turnpike
    City
    Wayne
    State
    NJ
    ZIP
    07470
    Country
    US
    Email
    [email protected]
    Phone
    800 9341034 ext. 1427

    Products

    Device Name Product Code
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB

    Proprietary Names

    REGIUS Cassette REGIUS Plate REGIUS Cassette/Plate REGIUS MODEL 210

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198