BEUDAMED
    FDA Registration Active 🇸🇮 Slovenia

    Sleepiz

    Reg #: 3015282442 · FEI: 3015282442 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    L-TEK D.O.O.
    Registration Number
    3015282442
    FEI Number
    3015282442
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Cesta Milosa Kovacicia
    City
    Sentjernej Ljubljana
    Country
    SI

    Regulatory Submissions

    510(k) Number
    K223163

    Owner / Operator

    Firm Name
    L-Tek d.o.o.
    Operator Number
    10059897
    Address
    Cesta Milosa Kovacica 2
    City
    Sentjernej
    State
    Ljubljana
    Postal Code
    8310
    Country
    SI

    US Agent

    Business Name
    Aztech Regulatory and Quality LLC
    Contact Name
    Joseph Azary
    Address
    543 Long Hill Ave
    City
    Shelton
    State
    CT
    ZIP
    06484
    Country
    US
    Email
    [email protected]
    Phone
    203 2426670

    Products

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

    Proprietary Names

    Sleepiz

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)