BEUDAMED
    FDA Registration Active 🇺🇸 United States

    YORLABS, INC.

    Reg #: 3038718997 · FEI: 3038718997 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    8
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    YORLABS, INC.
    Registration Number
    3038718997
    FEI Number
    3038718997
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2210 Faraday Ave Ste 100
    City
    Carlsbad
    State
    CA
    ZIP
    92008
    Country
    US

    Regulatory Submissions

    510(k) Number
    K250955

    Owner / Operator

    Firm Name
    YorLabs, Inc.
    Operator Number
    10094268
    Address
    8905 Southwest Nimbus Avenue, Suite 160
    City
    Beaverton
    State
    OR
    Postal Code
    97008
    Country
    US
    Correspondent
    Wanda Carpinella

    Products

    Device Name Product Code
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Catheter, Ultrasound, Intravascular OBJ
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    XC11 Communication Hub, USA XC11 ICE System, USA XC11 ICE System Cart, USA XC11 ICE System Disposable Knob, USA XC11 ICE Catheter (2D), USA XC11 ICE System Handle, USA XC11 ICE System Tablet, USA XC11 ICE Box Ultrasound System, USA

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device