Greer Medical, Inc. Certifications

Our Quality System has been certified to conform to ISO 13485:2003 Medical Device Quality Management Standard.  Certificate Number 2111770 endorsed by KEMA Quality B.V.
          Greer ISO13485 Certificate (PDF)

All of our medical devices are also CE Mark certified.  Endorsed by KEMA Quality B.V., CE 0344.

SeromaCath® Certificate Number 2113482CE01
<s-cathce link>  
Sapphire Suction Reservoir™ Certificate Number 2113482CE03
<sapphce link>  
SurgiFish®  Certificate Number 2113482CE02
<s-fishce link>  

Additionally, our devices are registered as Device Class 2, with the Medical Devices Bureau of the Therapeutic Products Directorate of Health Canada.  Manufacturer ID:  117097.

SeromaCath® License Number 71905
<s-cathcanada link>  
Sapphire Suction Reservoir™ License Number 71905
<sapphcanada link>  
SurgiFish® License Number 71905
<s-fishcanada link>  

 


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ISO 13485