BEUDAMED
    FDA Registration Active 🇨🇳 China

    CBP face mask

    Reg #: 3011529314 · FEI: 3011529314 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Nanjing J SUN Healthcare Co.,Ltd
    Registration Number
    3011529314
    FEI Number
    3011529314
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 1, Sanjiangkou Industrial Park, Jing'an, Qixia District
    City
    Nanjing Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K171961

    Owner / Operator

    Firm Name
    Nanjing J SUN Healthcare Co.,Ltd
    Operator Number
    10057025
    Address
    No. 1, Sanjiangkou Industrial Park, Jing'an, Qixia District
    City
    Nanjing
    State
    Jiangsu
    Postal Code
    210009
    Country
    CN

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Valve, Non-Rebreathing CBP

    Proprietary Names

    CBP face mask

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device