BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Envision 3D: Image Guidance System

    Reg #: 3013485140 · FEI: 3013485140 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ENGINEERING CPR INC.
    Registration Number
    3013485140
    FEI Number
    3013485140
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6720 Davand Dr. - Unit 20
    City
    mississauga Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K162375

    Owner / Operator

    Firm Name
    Engineering CPR Inc.
    Operator Number
    10053917
    Address
    6720 Davand Dr. - Unit 20
    City
    mississauga
    State
    Ontario
    Postal Code
    L5T 2K7
    Country
    CA
    Correspondent
    Taras Worona

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    Envision 3D: Image Guidance System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)