BEUDAMED
    FDA Registration Active 🇺🇸 United States

    mi-ultra LR

    Reg #: 3010760216 · FEI: 3010760216 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    TRICE MEDICAL
    Registration Number
    3010760216
    FEI Number
    3010760216
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    40 General Warren Blvd, Suite 100
    City
    Malvern
    State
    PA
    ZIP
    19355
    Country
    US

    Regulatory Submissions

    510(k) Number
    K163443

    Owner / Operator

    Firm Name
    Trice Medical
    Operator Number
    10046410
    Address
    40 General Warren Blvd, Suite 100
    City
    Malvern
    State
    PA
    Postal Code
    19355
    Country
    US
    Correspondent
    David Vancelette

    Products

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

    Proprietary Names

    mi-ultra LR mi-ultra CX

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device