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PPHIC products are manufactured to the strictest International Medical Equipment Standards and Certifications.
Our facilities, equipment and products are regularly audited by the various independent regulatory agencies.

  

Approved to International Medical Standards:  

IEC (International Electrotechnical Commision) - CB Certificate

 EC Certificate

Full Quality Assurance system Approval Certificate

(Annex II of the Directive 93/42/EEC on Medical Devices)

FDA Section 510(k) Cleared on 2001, Regulatory Class I

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