BEUDAMED
    FDA Registration Active 🇮🇳 India

    ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20

    Reg #: 3024894463 · FEI: 3024894463 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    DOLPHIN LIFE SCIENCE (INDIA) LLP
    Registration Number
    3024894463
    FEI Number
    3024894463
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Block No. 133, Village Dhamdod Nr. Hotel Supreme. Ta. Mangrol
    City
    Surat Gujarat
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K082746

    Owner / Operator

    Firm Name
    DOLPHIN LIFE SCIENCE (INDIA) LLP
    Operator Number
    10086427
    Address
    Block No. 133, Village Dhamdod Nr. Hotel Supreme. Ta. Mangrol
    City
    Surat
    State
    Gujarat
    Postal Code
    394125
    Country
    IN
    Correspondent
    Mukesh B Chovatiya

    US Agent

    Business Name
    AF Pharma Service Europe SL.
    Contact Name
    Mateo Carrasco
    Address
    1815 Barker drive
    City
    Winter Park
    State
    FL
    ZIP
    32789
    Country
    US
    Email
    [email protected]
    Phone
    407 2849480

    Products

    Device Name Product Code
    System, Balloon, Intra-Aortic And Control DSP

    Proprietary Names

    ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer) Manufacture Medical Device for Another Party (Contract Manufacturer)