BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    SENZIME AB

    Reg #: 3016490024 · FEI: 3016490024 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    SENZIME AB
    Registration Number
    3016490024
    FEI Number
    3016490024
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Verkstadsgatan 8
    City
    Uppsala
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K192595

    Owner / Operator

    Firm Name
    Senzime AB
    Operator Number
    10062527
    Address
    Verkstadsgatan 8
    City
    Uppsala
    State
    SE-C
    Postal Code
    75323
    Country
    SE
    Correspondent
    Johanna Faris

    Products

    Device Name Product Code
    Spirometer, Monitoring (W/Wo Alarm) BZK
    Monitor, Breathing Frequency BZQ

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198