BEUDAMED
    FDA Registration Active 🇨🇳 China

    Prostate Caddy™

    Reg #: 3007963782 · FEI: 3007963782 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Koo (Shanghai) Industries Co., Ltd
    Registration Number
    3007963782
    FEI Number
    3007963782
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    100 Zhongde Road, Xiaokunshan Town
    City
    Songjiang Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K150234

    Owner / Operator

    Firm Name
    KOO MFG, INC.
    Operator Number
    9012237
    Address
    100 Zhongde Road, Dakun Indurstrial Park
    City
    Songjiang
    State
    Shanghai
    Postal Code
    201613
    Country
    CN
    Correspondent
    CHRISTOPHER - KOO

    US Agent

    Business Name
    Promedic, LLC
    Contact Name
    Matt Dryden
    Address
    131 Bay Point Dr NE
    City
    Saint Petersburg
    State
    FL
    ZIP
    33704
    Country
    US
    Email
    [email protected]
    Phone
    239 3076063

    Products

    Device Name Product Code
    Prostate Immobilizer Rectal Balloon PCT

    Proprietary Names

    Prostate Caddy™

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)