FDA & CE Certifications

Plastiflex Healthcare obtained ISO 13485 and Annex II, MDD certification and CE marking for the Hybernite® ROC System. Plastiflex Healthcare is QSR compliant.

 


Original FDA document from the Food & Drug Administration Site

Plastiflex Healthcare,
ISO 13485


Plastiflex Healthcare,
Annex II, MDD - CE

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Medtrade 2012  -  coming soon

April 11 – 12, Las Vegas – Booth 735

October 16 – 18, Atlanta – Booth 763


Sleep (APSS)

June 9th – 13, Boston – Booth 624

 

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