BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    AURORA TECHNOLOGY PTE. LTD.

    Reg #: 3012796943 · FEI: 3012796943 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AURORA TECHNOLOGY PTE. LTD.
    Registration Number
    3012796943
    FEI Number
    3012796943
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    54 Serangoon North Avenue 4 Level 4 Singapore
    City
    Singapore North East
    Country
    SG

    Regulatory Submissions

    510(k) Number
    K132127

    Owner / Operator

    Firm Name
    Aurora Technology Pte. Ltd.
    Operator Number
    10083749
    Address
    54 Serangoon North Avenue 4 Level 4 Singapore
    City
    Singapore
    State
    North East
    Postal Code
    555854
    Country
    SG
    Correspondent
    Benny Lie

    US Agent

    Business Name
    Somnetics International, Inc
    Contact Name
    Mary Kay Jensen
    Address
    103 Osborne Road NE, Fridley, MN 55432
    City
    Fridley
    State
    MN
    ZIP
    55432
    Country
    US
    Email
    [email protected]
    Phone
    651 6211800

    Products

    Device Name Product Code
    Ventilator, Non-Continuous (Respirator) BZD

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)