BEUDAMED
    FDA Registration Active 🇳🇿 New Zealand

    Hailie Sensor

    Reg #: 3010047139 · FEI: 3010047139 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ADHERIUM (NZ) LTD
    Registration Number
    3010047139
    FEI Number
    3010047139
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Level 2, 63 Albert Street
    City
    Auckland
    Country
    NZ

    Regulatory Submissions

    510(k) Number
    K181405

    Owner / Operator

    Firm Name
    Adherium (NZ) Ltd
    Operator Number
    10046590
    Address
    Collins Square, Tower Four Level 18
    City
    727 Collins Street
    State
    AU-VIC
    Postal Code
    AU
    Country
    Victoria
    Correspondent
    Igbal Syre

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Nebulizer (Direct Patient Interface) CAF

    Proprietary Names

    Hailie Sensor

    Establishment Types

    Manufacture Medical Device