EC Certificate
Full 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 on 2001, Regulatory Class II
[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.]
