BEUDAMED
    FDA Registration Active 🇨🇳 China

    KLARITY MEDICAL & EQUIPMENT (GZ) CO., LTD.

    Reg #: 3003803149 · FEI: 3003803149 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    23
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    KLARITY MEDICAL & EQUIPMENT (GZ) CO., LTD.
    Registration Number
    3003803149
    FEI Number
    3003803149
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 6, Bihua Street, Huangpu District
    City
    Guangzhou Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K022708

    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

    US Agent

    Business Name
    Klarity Medical Products, LLC
    Contact Name
    Michelle Fritch
    Address
    600 Industrial Pkwy
    City
    Heath
    State
    OH
    ZIP
    43056
    Country
    US
    Email
    [email protected]
    Phone
    740 7888107 ext. 123

    Products

    Device Name Product Code
    Accelerator, Linear, Medical IYE
    Holder, Head, Radiographic IWY
    Splint, Hand, And Components ILH

    Proprietary Names

    KLARITY THERMOPLASTIC Klarity Thermoplastic Masks Klarity Promise Baseplate Klarity SRS Baseplate Klarity Leg Positioner Klarity SBRT System KLARITY BASEPLATES OPTEK BASEPLATES Klarity Prone Belly System Klarity Prone Breast System Klarity PelvicFix Baseplate Klarity Breastboard System Klarity SGRT System Klarity Bolus Klarity Head Cushion Klarity Vacuum Cushion TruForm Moldable Cushions AccuForm Cushions KS Splinting Material Contour Pro Splinting Material Contour Blend Splinting Material EzeFit¿ Splinting Material Klarity Splinting Material

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device