BEUDAMED
    FDA Registration Active 🇳🇿 New Zealand

    OviTex Reinforced Tissue Matrix with Resorbable Polymer (OviTex)

    Reg #: 3007321028 · FEI: 3007321028 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Aroa Biosurgery Ltd
    Registration Number
    3007321028
    FEI Number
    3007321028
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 Kingsford Smith Place
    City
    Airport Oaks Auckland
    Country
    NZ

    Regulatory Submissions

    510(k) Number
    K153633

    Owner / Operator

    Firm Name
    Aroa Biosurgery Ltd
    Operator Number
    10028943
    Address
    2 Kingsford Smith Place
    City
    Airport Oaks
    State
    Auckland
    Postal Code
    2022
    Country
    NZ
    Correspondent
    Stacey Spies

    US Agent

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

    Products

    Device Name Product Code
    Mesh, Surgical FTM

    Proprietary Names

    OviTex Reinforced Tissue Matrix with Resorbable Polymer (OviTex)

    Establishment Types

    Manufacture Medical Device