BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Aquanet EC-2000

    Reg #: 9615415 · FEI: 3006329956 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    PRIME PACIFIC HEALTH INNOVATIONS CORPORATION
    Registration Number
    9615415
    FEI Number
    3006329956
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1132 - 585 Seaborne Avenue
    City
    PORT COQUITLAM British Columbia
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K000031

    Owner / Operator

    Firm Name
    PRIME PACIFIC HEALTH INNOVATIONS CORPORATION
    Operator Number
    9035957
    Address
    1132 - 585 SEABORNE AVENUE, --
    City
    PORT COQUITLAM
    State
    British Columbia
    Postal Code
    V3B 0M3
    Country
    CA
    Correspondent
    DELMAR - VOGEL

    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
    Colonic Irrigation System KPL

    Proprietary Names

    Aquanet EC-2000 Aquanet APS-100 Aquanet GRY-500

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device