BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Prokera Slim

    Reg #: 3004802740 · FEI: 3009809074 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BioTissue Holdings Inc.
    Registration Number
    3004802740
    FEI Number
    3009809074
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8305 Nw 27th St, Suite 101
    City
    Doral
    State
    FL
    ZIP
    33122
    Country
    US

    Regulatory Submissions

    510(k) Number
    K032104

    Owner / Operator

    Firm Name
    BioTissue Holdings Inc.
    Operator Number
    9067198
    Address
    7300 Corporate Center Drive, Suite 700
    City
    Miami
    State
    FL
    Postal Code
    33126
    Country
    US
    Correspondent
    Alpesh Patel

    Products

    Device Name Product Code
    Conformer, Ophthalmic, Biological Tissue NQB

    Proprietary Names

    Prokera Slim Prokera Clear Prokera Classic Prokera Plus Prokera

    Establishment Types

    Manufacture Medical Device