BEUDAMED
    FDA Registration Active 🇨🇳 China

    Zoomax Luna S

    Reg #: 3014656175 · FEI: 3014656175 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    10
    Establishment Types
    10
    Classifications
    2

    Registration Details

    Registration Name
    ZOOMAX TECHNOLOGY CO., LIMITED
    Registration Number
    3014656175
    FEI Number
    3014656175
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9F, Building D, Paradise Software Park, No.3 Xidoumen Road
    City
    Hangzhou Zhejiang
    Country
    CN

    Owner / Operator

    Firm Name
    ZOOMAX TECHNOLOGY CO., LIMITED
    Operator Number
    10058836
    Address
    9F, Building D, Paradise Software Park, No.3 Xidoumen Road
    City
    Hangzhou
    State
    Zhejiang
    Postal Code
    310012
    Country
    CN
    Correspondent
    Stella Shen

    US Agent

    Business Name
    ZOOMAX (USA) INC.
    Contact Name
    Rebecca Chen
    Address
    6 Liberty Square #2572
    City
    Boston
    State
    MA
    ZIP
    02109
    Country
    US
    Email
    [email protected]
    Phone
    508 2866866

    Products

    Device Name Product Code
    Audiometer EWO
    Aid, Vision, Electronic, Battery-Powered HPG

    Proprietary Names

    Zoomax Luna S Zoomax Snow Pad Zoomax Luna 6 Zoomax Luna 8 Zoomax Snow 12 Insert Earphones Zoomax Luna HD 24 Pro Zoomax Acesight VR Zoomax Luna Eye Zoomax Snow Eye

    Establishment Types

    Repack or Relabel Medical Device Sterilize Medical Device for Another Party (Contract Sterilizer) Develop Specifications But Do Not Manufacture At This Facility Remanufacture Medical Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Foreign Private Label Distributor Export Device to the United States But Perform No Other Operation on Device Complaint File Establishment per 21 CFR 820.198 Reprocess Single-Use Device