BEUDAMED
    FDA Registration Active 🇱🇰 Sri Lanka

    Ispira Resuscitation System Circuit; NeoPIP Neonatal Resuscitation Kit; NeoPIP Resuscitation Circuit with PEEP

    Reg #: 3017202422 · FEI: 3017202422 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Flexicare Lanka (Pvt) Ltd
    Registration Number
    3017202422
    FEI Number
    3017202422
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    382/x, Kumbuka Road, Raigama
    City
    Bandaragama Western
    Country
    LK

    Regulatory Submissions

    510(k) Number
    K103833

    Owner / Operator

    Firm Name
    FLEXICARE MEDICAL LTD.
    Operator Number
    8021995
    Address
    CYNON VALLEY BUSINESS PARK
    City
    MOUNTAIN ASH
    State
    Rhondda Cynon Taff
    Postal Code
    CF45 4ER
    Country
    GB
    Correspondent
    Khashayar - Poormand

    Products

    Device Name Product Code
    Attachment, Breathing, Positive End Expiratory Pressure BYE

    Proprietary Names

    Ispira Resuscitation System Circuit; NeoPIP Neonatal Resuscitation Kit; NeoPIP Resuscitation Circuit with PEEP

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)