BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    CapnoDura Combi, CapnoDura Pedi

    Reg #: 3006307105 · FEI: 3006307105 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MedDev Manufacturing Sdn Bhd
    Registration Number
    3006307105
    FEI Number
    3006307105
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2nd Floor, Lot 2552, Wisma Kierie, Jalan Seruling 59,, Kaw. 3, Taman Klang Jaya
    City
    Klang Selangor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K112840

    Owner / Operator

    Firm Name
    SeeBreath AB
    Operator Number
    10041602
    Address
    Birger Jarlsgatan 2
    City
    Stockholm
    State
    SE-AB
    Postal Code
    11434
    Country
    SE
    Correspondent
    Anette Sjogren

    US Agent

    Business Name
    QRx Partners
    Contact Name
    Mark Swanson
    Address
    16904-77th Street SE
    City
    Becker
    State
    MN
    ZIP
    55308
    Country
    US
    Email
    [email protected]
    Phone
    763 2340727

    Products

    Device Name Product Code
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK

    Proprietary Names

    CapnoDura Combi, CapnoDura Pedi

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)