BEUDAMED
    FDA Registration Active 🇳🇿 New Zealand

    Digital Knee DK-013

    Reg #: 3015766032 · FEI: 3015766032 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    OPUM TECHNOLOGIES SERVICES
    Registration Number
    3015766032
    FEI Number
    3015766032
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    University of Auckland Newmarket Campus, Building 903, 314-390 Khyber Pass Road, Newmarket, Auckland, 1023 , N, Khyber Pass Road,
    City
    Newmarket Auckland
    Country
    NZ

    Owner / Operator

    Firm Name
    OPUM TECHNOLOGIES SERVICES LIMITED
    Operator Number
    10089032
    Address
    University of Auckland Newmarket Campus, Building 903, 314-390 Khyber Pass Road, Newmarket
    City
    Auckland
    State
    NZ-AUK
    Postal Code
    1023
    Country
    NZ
    Correspondent
    Alexandra J Wilson

    US Agent

    Business Name
    OPUM US INC
    Contact Name
    Freeborn Mondello
    Address
    1160 Battery Street East, Suite 100 - #1066
    City
    San Francisco
    State
    CA
    ZIP
    94111
    Country
    US
    Email
    [email protected]
    Phone
    818 3019200

    Products

    Device Name Product Code
    Goniometer, Ac-Powered KQX

    Proprietary Names

    Digital Knee DK-013 Digital Knee DK-009 Digital Knee DK-016 Digital Knee DK-011 Digital Knee DK-014 Digital Knee DK-010 Digital Knee DK-015 Digital Knee DK-008 Digital Knee DK-012

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device