BEUDAMED
    FDA Registration Active 🇨🇳 China

    PressureChek

    Reg #: 3005998497 · FEI: 3005998497 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SUNMED AP, LTD.
    Registration Number
    3005998497
    FEI Number
    3005998497
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6-9 ZHUFENG RD., QIANNAN INDUSTRIAL PARK, QIANWU TOWN, DOUMEN DISTRICT
    City
    ZHUHAI Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K120118

    Owner / Operator

    Firm Name
    VENTLAB, LLC
    Operator Number
    2246980
    Address
    2710 Northridge Dr. NW, Suite A, --
    City
    Grand Rapids
    State
    MI
    Postal Code
    49544
    Country
    US
    Correspondent
    Rob Yamashita

    Products

    Device Name Product Code
    Monitor, Airway Pressure (Includes Gauge And/Or Alarm) CAP

    Proprietary Names

    PressureChek

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)