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.
<isocertificate link>
All of our medical devices are also CE Mark certified. Endorsed by KEMA Quality B.V., CE 0344.
| SeromaCath® | Certificate Number CE6764.01 |
| <s-cathce link> | |
| Sapphire Suction Reservoir™ | Certificate Number CE3499.03 |
| <sapphce link> | |
| SurgiFish® | Certificate Number CE6764.02 |
| <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> |
|top|
|
|
||
0334