BEUDAMED
    FDA Registration Active 🇨🇳 China

    Runyes Dental Digital Imaging Sensor

    Reg #: 3008252267 · FEI: 3008252267 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Ningbo Runyes Medical Instrument Co., Ltd.
    Registration Number
    3008252267
    FEI Number
    3008252267
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 456 Tonghui Road, Jiangbei Investment & Pioneering Par C
    City
    Ningbo Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K210312

    Owner / Operator

    Firm Name
    Ningbo Runyes Medical Instrument Co., Ltd.
    Operator Number
    10052869
    Address
    No. 456 Tonghui road, Jiangbei Investment & Pioneering Park C
    City
    Ningbo
    State
    CN-NOTA
    Postal Code
    315033
    Country
    CN

    US Agent

    Business Name
    510kfda, Inc
    Contact Name
    Claude Berthoin
    Address
    156 E Granada Blvd
    City
    Ormond Beach
    State
    FL
    ZIP
    32176
    Country
    US
    Email
    [email protected]
    Phone
    386 8710908

    Products

    Device Name Product Code
    System, X-Ray, Extraoral Source, Digital MUH

    Proprietary Names

    Runyes Dental Digital Imaging Sensor

    Establishment Types

    Foreign Private Label Distributor Export Device to the United States But Perform No Other Operation on Device Repack or Relabel Medical Device