BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    PRIME PACIFIC HEALTH INNOVATIONS CORPORATION

    Reg #: 9615415 · FEI: 3006329956 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    PRIME PACIFIC HEALTH INNOVATIONS CORPORATION
    Registration Number
    9615415
    FEI Number
    3006329956
    Status
    Active
    Expiry Year
    2026
    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
    Chair And Table, Medical KMN
    Connector, Catheter GCD
    Colonic Irrigation System KPL
    Speculum, Rectal FFQ

    Proprietary Names

    AquaWing FlexTube Aquanet EC-2000 Aquanet APS-100 Aquanet GRY-500 Speculum and Kits, Disposable

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device