Prime Pacific Health Innovations Corporation is proud to be an ISO 9001:2000 & ISO 13485:2003 certified medical equipment manufacturer. Our products are manufactured to the strictest international medical equipment standards and our facilities/systems are regularly audited by various independent agencies. We continually work to bring you products that are of the highest quality.
Our products are cleared or certified by various international organizations:
 |
 |
 |
 |
|
|||
Our Quality Management System is certified to ISO 9001:2000 and ISO 13485:2003 Standards:
 |
 |
Certificates, Licences, and Registrations
IEC (International Electrotechnical Commision) - CB Certificate |
EC CertificateFull Quality Assurance system Approval Certificate(Annex II of the Directive 93/42/EEC on Medical Devices) |
ISO 9001:2000 Global Certification Network Certificate |
ISO 9001:2000 Global Certificate of Registration |
ISO 13485:2003 Certificate of Registration |
Health Canada Medical Device Licence |
CSA Certificate of Compliance to Medical Standards |
FDA Section 510(k) Cleared, Regulatory Class II - Aquanet EC-2000 |
[Note: In the USA, Class II Colon Hydrotherapy devices are regulated by the FDA (Food and Drug Administration) as follows: Federal Law restricts this device to sale by or on the order of a physician. This means that within the USA, all Class II Colon Irrigation Devices are prescription devices and their purchase and use must be authorized with a prescription by a practitioner licensed by state law to use such devices in that state.]
