Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR)
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) requires that the manufacturer shall draw up a summary of safety and performance (SSP) for class C and D devices, other than devices for performance studies. The SSP shall be validated by a notified body (NB) and made available to the public via the European database on medical devices (EUDAMED).
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No. |
Brand Names |
In-house model name |
|
1 |
RIGHTEST Blood Glucose Monitoring System GM550 |
GM550 |
|
2 |
LineaD Blood Glucose Monitoring System EVO |
|
|
3 |
mylife Pura Blood Glucose Monitoring System |
|
|
4 |
mylife Pura X Blood Glucose Monitoring System |
|
|
5 |
CLICKS Bionime Blood Glucose Monitoring System GM550 |
|
|
6 |
GE Blood Glucose Monitoring System GM550 |
