BEUDAMED
    FDA Registration Active 🇳🇿 New Zealand

    kerasorb

    Reg #: 3007662962 · FEI: 3007662962 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Keraplast Limited
    Registration Number
    3007662962
    FEI Number
    3007662962
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    520 Waterloo Road, Islington
    City
    Christchurch Canterbury
    Country
    NZ

    Regulatory Submissions

    510(k) Number
    K080949

    Owner / Operator

    Firm Name
    Keraplast Limited
    Operator Number
    10029344
    Address
    520 Waterloo Road, Islington
    City
    Christchurch
    State
    Canterbury
    Postal Code
    8042
    Country
    NZ
    Correspondent
    Cindy-Lee Prinsloo

    US Agent

    Business Name
    BioWound Solutions
    Contact Name
    John Rogers
    Address
    6823 W Post Rd
    City
    Las Vegas
    State
    NV
    ZIP
    89118
    Country
    US
    Email
    [email protected]
    Phone
    661 3124018

    Products

    Device Name Product Code
    Dressing, Wound, Drug FRO

    Proprietary Names

    kerasorb keragelT keragel keramatrix

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer) Manufacture Medical Device for Another Party (Contract Manufacturer)