BEUDAMED
    FDA Registration Active 🇨🇳 China

    Clear Aligner(EAB II)

    Reg #: 3013556527 · FEI: 3013556527 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    WUXI EA MEDICAL INSTRUMENTS TECHNOLOGIES LIMITED
    Registration Number
    3013556527
    FEI Number
    3013556527
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1F, building 1 and building 2, No. 1619, Huishan Avenue, Huishan Economic Development Zone
    City
    Wuxi Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K203688

    Owner / Operator

    Firm Name
    Wuxi EA Medical Instruments Technologies Limited
    Operator Number
    10060304
    Address
    No. 1619, Huishan Avenue, Huishan Economic Development Zone, Wuxi, China 214000
    City
    Wuxi
    State
    CN-NOTA
    Postal Code
    214000
    Country
    CN
    Correspondent
    Jessica Luo

    US Agent

    Business Name
    Prime Path Medtech, Inc.
    Contact Name
    Bill Jacqmein
    Address
    811 Lakeview Drive Shoreview
    City
    Arden Hills
    State
    MN
    ZIP
    55126
    Country
    US
    Email
    [email protected]
    Phone
    404 2166190

    Products

    Device Name Product Code
    Aligner, Sequential NXC

    Proprietary Names

    Clear Aligner(EAB II)

    Establishment Types

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