BEUDAMED
    FDA Registration Active 🇮🇳 India

    Cocoon Convective Warming System, Model CWS7000

    Reg #: 3012315097 · FEI: 3012315097 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CARE ESSENTIALS INTERNATIONAL PVT LTD.
    Registration Number
    3012315097
    FEI Number
    3012315097
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Naman Estate, Building No. 2, Survey No 527 & 528, Opposite Pharmez, MatodaTaluka Sanand, NH 8A
    City
    Ahmedabad Gujarat
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K232502

    Owner / Operator

    Firm Name
    CARE ESSENTIALS PTY LTD
    Operator Number
    10048196
    Address
    103 Mornington Street
    City
    North Geelong
    State
    Victoria
    Postal Code
    3215
    Country
    AU
    Correspondent
    ABHAY SINHA

    US Agent

    Business Name
    Medical Solutions, Inc.
    Contact Name
    Manny Sok
    Address
    3901 Centerview Dr Ste L
    City
    Fairfax
    State
    VA
    ZIP
    20151
    Country
    US
    Email
    [email protected]
    Phone
    703 9957179

    Products

    Device Name Product Code
    System, Thermal Regulating DWJ

    Proprietary Names

    Cocoon Convective Warming System, Model CWS7000

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)