Prime Pacific is proud to be ISO 13485:2003 certified for the manufacture of medical devices.
All of our colon hydrotherapy devices are manufactured to the highest international medical standards. This means our facilities and systems are regularly audited by regulatory and certifying agencies to ensure we continue supplying you with safe and effective devices that meet the highest international quality assurance standards for medical devices.
It also means we must continually work to improve our products.
All our devices are built and tested to the hightest quality assured international medical standards
Quality Management System Certified to ISO 13485:2003 international standards
Certificates, Licences, and Registrations
ISO 13485:2003 Certificate of Registration
FDA Section 510(k) Cleared, Regulatory Class II (FDA GMP)
Health Canada Medical Device License (CMDCAS)
CE Marked (0413)
EC Certificate – Full Quality Assurance System Approval Certificate (Annex II of the Directive 93/42/EEC on Medical Devices)
CSA Certificate of Compliance to Medical Standards
IEC (International Electrotechnical Commission) – CB Test Certificate
Please Note: In the USA class II Colon Hydrotherapy devices including speculums and treatment kits are regulated by the FDA. Regulations restrict the sales of these items by or on the order of a physician. Their purchase and use must be authorized by a medical professional licensed in your jurisdiction.