BEUDAMED
    FDA Registration Active 🇨🇳 China

    CARE ZY5BA Oxygen Concentrator

    Reg #: 3008220943 · FEI: 3008220943 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD.
    Registration Number
    3008220943
    FEI Number
    3008220943
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    #2 Haitang Rd, National Ecological Industrial Park, Danzao, Town, Nanhai District
    City
    Foshan Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K102245

    Owner / Operator

    Firm Name
    Foshan Care Medical Technology Co., Ltd.
    Operator Number
    10036239
    Address
    #2 Haitang Rd, National Ecological Industrial Park, Danzao Town, Nanhai District
    City
    Foshan
    State
    Guangdong
    Postal Code
    528000
    Country
    CN
    Correspondent
    Leona Zhou

    US Agent

    Business Name
    PUREVISION AI, INC.
    Contact Name
    DJ Fang
    Address
    111 Town Square Place, Suite 1203
    City
    Jersey City
    State
    NJ
    ZIP
    07310
    Country
    US
    Email
    [email protected]
    Phone
    201 5035758

    Products

    Device Name Product Code
    Generator, Oxygen, Portable CAW

    Proprietary Names

    CARE ZY5BA Oxygen Concentrator

    Establishment Types

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