BEUDAMED
    FDA Registration Active 🇨🇳 China

    Luna1012X Wireless Digital Flat Panel Detector

    Reg #: 3013186032 · FEI: 3013186032 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    iRay Group
    Registration Number
    3013186032
    FEI Number
    3013186032
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.999, Huanqiao Road, Pudong New Area
    City
    Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K221345

    Owner / Operator

    Firm Name
    iRay Group
    Operator Number
    10052663
    Address
    No.999, Huanqiao Road, Pudong New Area
    City
    Shanghai
    State
    CN-SH
    Postal Code
    201315
    Country
    CN
    Correspondent
    Wei Pan

    US Agent

    Business Name
    MID-LINK INTERNATIONAL Co., Ltd.
    Contact Name
    Marco Mu
    Address
    2219 Rimland Dr. Suite 301
    City
    Bellingham
    State
    WA
    ZIP
    98226
    Country
    US
    Email
    [email protected]
    Phone
    360 3257028

    Products

    Device Name Product Code
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB

    Proprietary Names

    Luna1012X Wireless Digital Flat Panel Detector Mano2530F Wireless Digital Flat Panel Detector Mano2530A Wireless Digital Flat Panel Detector

    Establishment Types

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