BEUDAMED
    FDA Registration Active 🇨🇳 China

    iRay Group

    Reg #: 3013186032 · FEI: 3013186032 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    31
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    iRay Group
    Registration Number
    3013186032
    FEI Number
    3013186032
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.999, Huanqiao Road, Pudong New Area
    City
    Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K221714

    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 Rimlang Drive, Suite 301
    City
    Bellingham
    State
    WA
    ZIP
    98226
    Country
    US
    Email
    [email protected]
    Phone
    702 2095185

    Products

    Device Name Product Code
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Extraoral Source, Digital MUH
    System, Image Processing, Radiological LLZ
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF

    Proprietary Names

    Venu1717X Mano4343T Mano4343X Venu1748V Mercu1717V Luna1012X Wireless Digital Flat Panel Detector Mano2530F Wireless Digital Flat Panel Detector Mano2530A Wireless Digital Flat Panel Detector Mars1417V-PSI Mars1717XF-GSI Mars1417X Wireless Digital Flat Panel Detector Mano4336A Wireless Digital Flat Panel Detector Mano4336F Wireless Digital Flat Panel Detector Mars1417V-TSI & Mano4336W Mars1013X CS 6200 Digital Intraoral X-Ray Sensor Mars1717X Wireless Digital Flat Panel Detector Mano4343F Wireless Digital Flat Panel Detector Mano4343A Wireless Digital Flat Panel Detector Pluto0002XW Digital Radiographic Imaging Acquisition Software - DR (RiasDR) Mars1717V-VSI and Mano4343W Mars1717XF-CSI Pluto0001X Digital Intraoral X-ray Imaging System Pluto0000X Digital Intraoral X-ray Imaging System Pluto0015X Digital Intraoral X-ray Imaging System Pluto0002X Digital Intraoral X-ray Imaging System Mars1417XF-CSI Venu1748V-WF, DRX-LC iScan Mars1417XF-GSI

    Establishment Types

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