BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    Sleepiz One+

    Reg #: 3020207731 · FEI: 3020207731 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Sleepiz AG
    Registration Number
    3020207731
    FEI Number
    3020207731
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Hornbachstrasse 23
    City
    Zurich
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K223163

    Owner / Operator

    Firm Name
    Sleepiz AG
    Operator Number
    10083842
    Address
    Hornbachstrasse 23
    City
    Zurich
    State
    CH-ZH
    Postal Code
    8008
    Country
    CH
    Correspondent
    Marta Stepien

    Products

    Device Name Product Code
    Monitor, Breathing Frequency BZQ
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT

    Proprietary Names

    Sleepiz One+

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device