BEUDAMED
    FDA Registration Active 🇨🇳 China

    Klarity SBRT System

    Reg #: 3003803149 · FEI: 3003803149 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KLARITY MEDICAL & EQUIPMENT (GZ) CO., LTD.
    Registration Number
    3003803149
    FEI Number
    3003803149
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 6, Bihua Street, Huangpu District
    City
    Guangzhou Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K112460

    Owner / Operator

    Firm Name
    KLARITY MEDICAL & EQUIPMENT (GZ) CO, LTD.
    Operator Number
    9050591
    Address
    No. 6, Bihua Street, Huangpu District
    City
    Guangzhou
    State
    Guangdong
    Postal Code
    510730
    Country
    CN
    Correspondent
    Michelle P Fritch

    US Agent

    Business Name
    Klarity Medical Products, LLC
    Contact Name
    PETER LARSON
    Address
    600 Industrial Parkway
    City
    Heath
    State
    OH
    ZIP
    43056
    Country
    US
    Email
    [email protected]
    Phone
    740 7888107 ext. 111

    Products

    Device Name Product Code
    Accelerator, Linear, Medical IYE

    Proprietary Names

    Klarity SBRT System Klarity Leg Positioner OPTEK BASEPLATES KLARITY BASEPLATES Klarity Prone Breast System Klarity Prone Belly System Klarity PelvicFix Baseplate Klarity Breastboard System

    Establishment Types

    Manufacture Medical Device