BEUDAMED
    FDA Registration Active 🇳🇿 New Zealand

    ENZTEC LIMITED

    Reg #: 3004641308 · FEI: 3004641308 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    ENZTEC LIMITED
    Registration Number
    3004641308
    FEI Number
    3004641308
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3/17 PRINT PLACE, MIDDLETON
    City
    CHRISTCHURCH Canterbury
    Country
    NZ

    Regulatory Submissions

    510(k) Number
    K140975

    Owner / Operator

    Firm Name
    ENZTEC LIMITED
    Operator Number
    9084846
    Address
    3/17 Print Place, Middleton, --
    City
    Christchurch
    State
    Canterbury
    Postal Code
    8024
    Country
    NZ
    Correspondent
    Kate - Moorhead

    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
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)