BEUDAMED
    FDA Registration Active 🇨🇳 China

    CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD.

    Reg #: 3016875543 · FEI: 3016875543 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    29
    Establishment Types
    2
    Classifications
    14

    Registration Details

    Registration Name
    CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD.
    Registration Number
    3016875543
    FEI Number
    3016875543
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 26 Yandanghe Road, Xinbei District
    City
    Changzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K221152

    Owner / Operator

    Firm Name
    Changzhou Sifary Medical Technology Co., Ltd.
    Operator Number
    10074229
    Address
    No. 26 Yandanghe Road, Xinbei District
    City
    Changzhou
    State
    Jiangsu
    Postal Code
    213000
    Country
    CN
    Correspondent
    Jie Zhu

    US Agent

    Business Name
    Dynasty Medical Consulting Inc.
    Contact Name
    Linda Chen
    Address
    302 Round Lake Dr
    City
    Rosenberg
    State
    TX
    ZIP
    77469
    Country
    US
    Email
    [email protected]
    Phone
    832 3809688

    Products

    Device Name Product Code
    Activator, Ultraviolet, For Polymerization EBZ
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF
    Unit, X-Ray, Extraoral With Timer EHD
    System, X-Ray, Extraoral Source, Digital MUH
    X-Ray, Tomography, Computed, Dental OAS
    File, Pulp Canal, Endodontic EKS
    Plugger, Root Canal, Endodontic EKR
    Locator, Root Apex LQY
    Microscope, Surgical EPT
    Accessories, Implant, Dental, Endosseous NDP
    Pick, Massaging JET
    Loupe, Diagnostic/Surgical FSP
    Light, Surgical Headlight EBA
    Handpiece, Direct Drive, Ac-Powered EKX

    Proprietary Names

    CuringPen Dental Curing Light Intraoral Scanner, Helios 600, Helios 500, MyScanner, Helios 680, Helios 560, Helios 700, INNO SCAN HyperLight Portable X-ray Unit Dental Sensors NanoPix1, NanoPix2, NanoPix1.5, Brand: Eighteeth Dental Sensors V-Sensor1, V-Sensor2 Dental Cone-beam Computed Tomography (model: FinScan F350) E-STYLE GOLD, E-STYLE BLUE, E-Aurora E-FLEX, E-FLEX S, E-FLEX BLUE, E-FLEX GOLD, E-FLEX EDGE, E-FLEX RT, E-FLEX REC, E-FLEX ONE, E-FLEX MINI Z-Up; Z-Down Endodontic Obturation Device, Fast-Fill, Fast-Pack pro Endodontic Obturation Device, Space-Fill, Space-Pack Apex Locator, FindPex Surgical Microscope, Acuvision X Orion SC-M1.4, Orion SC-M1.6, Orion SC-M1.8, Orion D Orion SL-M1.4, Orion SL-M1.6, Orion SL-M1.8 Orion SM-M1.4, Orion SM-M1.6, Orion SM-M1.8 Orion Kit-M1.4, Orion Kit-M1.6, Orion Kit-M1.8 Orion SS-M1.4, Orion SS-M1.6, Orion SS-M1.8 Ultra X SurfyOne ibT5035T, ibT5040T, ibT5045T, ibT5050T, ibT7235T, ibT7240T, ibT7245T, ibT7250T Surgical Binocular Loupes, ibG3035D, ibG3040D, ibG3045D, ibG3050D, ibG3035S, ibG3040S, ibG3045S, ibG3050S Surgical Binocular Loupes, ibG3535D, ibG3540D, ibG3545D, ibG3550D, ibG3535S, ibG3540S, ibG3545S, ibG3550S, ibT5045 ibG2535T, ibG2540T, ibG2545T, ibG2550T, ibG3035T, ibG3040T, ibG3045T, ibG3050T ibT3035T, ibT3040T, ibT3045T, ibT3050T, ibT4035T, ibT4040T, ibT4045T, ibT4050T Surgical Binocular Loupes, ibT5035+, ibT5040+, ibT5045+, ibT5050+ Surgical Headlight, Wireless Z, Lux-SFT, Wireless Z+ E-Connect S Endo Motor With Built-In Apex Locator Z-Evo

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device