BEUDAMED
    FDA Registration Active 🇨🇳 China

    NovaLine SP-C35 Transducer Protector

    Reg #: 3013217742 · FEI: 3013217742 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BAIN MEDICAL EQUIPMENT(GUANGZHOU) CO., LTD.
    Registration Number
    3013217742
    FEI Number
    3013217742
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.10 Juncheng Road, Eastern Zone of Guangzhou Economic & Technological Development District
    City
    Guangzhou Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K240164

    Owner / Operator

    Firm Name
    Bain Medical Equipment(Guangzhou) Co., Ltd.
    Operator Number
    10059567
    Address
    No.10 Juncheng Road, Eastern Zone of Guangzhou Economic & Technological Development District
    City
    Guangzhou
    State
    Guangdong
    Postal Code
    510760
    Country
    CN
    Correspondent
    Zoe Zeng

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Protector, Transducer, Dialysis FIB

    Proprietary Names

    NovaLine SP-C35 Transducer Protector

    Establishment Types

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