BEUDAMED
    FDA Registration Active 🇨🇳 China

    Ningbo Runyes Medical Instrument Co., Ltd.

    Reg #: 3008252267 · FEI: 3008252267 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    23
    Establishment Types
    6
    Classifications
    4

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    Registration Details

    Registration Name
    Ningbo Runyes Medical Instrument Co., Ltd.
    Registration Number
    3008252267
    FEI Number
    3008252267
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 456 Tonghui Road, Jiangbei Investment & Pioneering Park C
    City
    Ningbo Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K252909

    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
    Unit, X-Ray, Extraoral With Timer EHD
    System, X-Ray, Extraoral Source, Digital MUH
    Intraoral Camera QJK
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF

    Proprietary Names

    Diagnostic X-Ray Equipment POCT22 Runyes Dental Digital Imaging Sensor X-Ray Diagnostic Equipment RAY68 (W) X-Ray Diagnostic Equipment RAY68 (M) TeliCam Diagnostic X-Ray Equipment RAY88(P) Diagnostic X-Ray Equipment RAY98(P) Diagnostic X-Ray Equipment MobileX R98 Runyes 3DS Intraoral Scanner IOS-11 Intraoral Scanner SCAN-O5 Intraoral Scanner SCAN33 Intraoral Scanner SCAN11 Intraoral Scanner SCAN-i5 iGrapher Intraoral Scanner 3DS Mega Intraoral Scanner ORAL-O3 Intraoral Scanner R2i3 QuickScanIOS Intraoral Scanner SCAN-O6 Intraoral Scanner SCAN-V5 Intraoral Scanner 3DS Ultra Intraoral Scanner SCAN-V6 Intraoral Scanner SCAN-i6

    Establishment Types

    Manufacture Medical Device Foreign Private Label Distributor Export Device to the United States But Perform No Other Operation on Device Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198