BEUDAMED
    FDA Registration Active 🇨🇳 China

    IV Set

    Reg #: 3004215921 · FEI: 3004215921 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DRAGON HEART MEDICAL DEVICES CO., LTD.
    Registration Number
    3004215921
    FEI Number
    3004215921
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    28 Ruliang Road, Baihe Town,
    City
    Kaiping Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K101368

    Owner / Operator

    Firm Name
    DRAGON HEART MEDICAL DEVICES CO., LTD.
    Operator Number
    9059702
    Address
    28 Ruliang Road, Baihe Town
    City
    Kaiping
    State
    Guangdong
    Postal Code
    529375
    Country
    CN
    Correspondent
    SAM - WONG

    US Agent

    Business Name
    Dragon Heart Medical, Inc.
    Contact Name
    Jina Yu
    Address
    11101 Franklin Ave, Ste 100
    City
    Franklin Park
    State
    IL
    ZIP
    60131
    Country
    US
    Email
    [email protected]
    Phone
    312 6989168

    Products

    Device Name Product Code
    Set, Administration, Intravascular FPA

    Proprietary Names

    IV Set

    Establishment Types

    Manufacture Medical Device