BEUDAMED
    FDA Registration Active 🇱🇰 Sri Lanka

    Peak Air PF9940 Peak Flow Meter

    Reg #: 3017202422 · FEI: 3017202422 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    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
    K982334

    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
    Meter, Peak Flow, Spirometry BZH

    Proprietary Names

    Peak Air PF9940 Peak Flow Meter AIRZONE EVALUPEAK ATS CURAPLEX AIRZONE (MEDLINE) 12X36 BOX AIRZONE WHITE (AIRIAL) AIRZONE BLUE ATS (US) SINGLE AIRZONE BLUE ATS (EUROPE) CE

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)