BEUDAMED
    FDA Registration Active 🇨🇳 China

    MOBINEURO Alita Intraoperative MRI System

    Reg #: 3027325776 · FEI: 3027325776 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SINO CANADA HEALTH ENGINEERING RESEARCH INSTITUTE (HEFEI) LTD. (SCHERI)
    Registration Number
    3027325776
    FEI Number
    3027325776
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Building B5 National Health Big Data Industrial Park, Intersection of Xiyou Road and Kongquetai Road, High-tech Zone
    City
    Hefei Anhui
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K223875

    Owner / Operator

    Firm Name
    Sino Canada Health Engineering Research Institute (Hefei) Lt
    Operator Number
    10086903
    Address
    Building B5 National Health Big Data Industrial Park, Intersection of Xiyou Road and Kongquetai Road, High-tech Zone
    City
    Hefei
    State
    Anhui
    Postal Code
    230088
    Country
    CN
    Correspondent
    Danijela Domljanovic

    Products

    Device Name Product Code
    System, Nuclear Magnetic Resonance Imaging LNH

    Proprietary Names

    MOBINEURO Alita Intraoperative MRI System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device