BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    PrizMCurgN

    Reg #: 3026753388 · FEI: 3026753388 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SmartSurgN Sdn Bhd
    Registration Number
    3026753388
    FEI Number
    3026753388
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 8, Jalan Alfa Impian 1, Taman Perindustrian Alfa Impian
    City
    Balakong Selangor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K213943

    Owner / Operator

    Firm Name
    SmartSurgN Incorporated
    Operator Number
    10077144
    Address
    325 S 1st Street, Suite 120
    City
    San Jose
    State
    CA
    Postal Code
    95113
    Country
    US

    US Agent

    Business Name
    SmartSurgN Inc
    Contact Name
    Jocelyn Long
    Address
    1038 Leigh Avenue, Suite 101B
    City
    San Jose
    State
    CA
    ZIP
    95126
    Country
    US
    Email
    [email protected]
    Phone
    408 8028586

    Products

    Device Name Product Code
    Confocal Optical Imaging OWN

    Proprietary Names

    PrizMCurgN EyeRSurgN IRLightSurgN OpticRSurgN AA Medical

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198