Summary of Safety and Performance (SSP)

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).

 

No.

Brand Names

In-house model name

SSP download

1

RIGHTEST Blood Glucose Monitoring System GM550

GM550








After SSP undergoes review by the NOTIFIED BODY, a new file will be uploaded.

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

7

RIGHTEST ALPHA Blood Glucose Monitoring System
GM551		 After SSP undergoes review by the NOTIFIED BODY, a new file will be uploaded.

8

RIGHTEST ELSA Blood Glucose Monitoring System


GM111

After SSP undergoes review by the NOTIFIED BODY, a new file will be uploaded.
9 Blood Glucose Monitoring System Prolife PM200
10 GE GlucoCapture ELSA Blood Glucose Monitoring System
11 RIGHTEST Blood Glucose Monitoring System GM700S
GM780

After SSP undergoes review by the NOTIFIED BODY, a new file will be uploaded.
12 EVOCHECK Blood Glucose Monitoring System GM700S
13 Circa Validio Blood Glucose Monitoring System
14 GE GlucoCapture Oro Blood Glucose Monitoring System
15 Rightest Max Tel Blood Glucose Monitoring System
GM777		 After SSP undergoes review by the NOTIFIED BODY, a new file will be uploaded.
16 Vivora glucoTel Blood Glucose Monitoring System
17 RIGHTEST Blood Glucose Monitoring System GM260
GM260

 After SSP undergoes review by the NOTIFIED BODY, a new file will be uploaded.
18 GlucoRite Blood Glucose Monitoring System GM260
19 RIGHTEST Blood Glucose Monitoring System GM700SB



GM782


After SSP undergoes review by the NOTIFIED BODY, a new file will be uploaded.
20 RIGHTEST Blood Glucose Monitoring System GM700SB
21 LineaD ORO 24 Blood Glucose Monitoring System
22 GE GlucoCapture Oro Plus Blood Glucose Monitoring System
23 GLUCOSTADA Blood Glucose Monitoring System
24 RIGHTEST Wiz Plus Blood Glucose Monitoring System

GM572
After SSP undergoes review by the NOTIFIED BODY, a new file will be uploaded.
25 GE Wiz Plus Blood Glucose Monitoring System
26 GE GlucoCapture Wiz Plus Blood Glucose Monitoring System
27 RIGHTEST Blood Glucose Monitoring System GM720
GM721		 After SSP undergoes review by the NOTIFIED BODY, a new file will be uploaded.
28 Blood Glucose Monitoring System LineaD ORO
29 mylife Unio Blood Glucose Monitoring System GM720 After SSP undergoes review by the NOTIFIED BODY, a new file will be uploaded.
30 GE Blood Glucose Monitoring System GE100 GM555 After SSP undergoes review by the NOTIFIED BODY, a new file will be uploaded.
31 RΕΑL CARE Blood Glucose Monitoring System RC100
32 RIGHTEST Blood Glucose Monitoring System GM700

GM700
After SSP undergoes review by the NOTIFIED BODY, a new file will be uploaded.
33 GE GlucoCapture Oro Pro Blood Glucose Monitoring System
34 Blood Glucose Monitoring System LineaD ORO HR
35 RIGHTEST Max Plus Blood Glucose Monitoring System

GM772
After SSP undergoes review by the NOTIFIED BODY, a new file will be uploaded.
36 GE Max Plus Blood Glucose Monitoring System
37 Vivora gluco Blood Glucose Monitoring System
38 RIGHTEST Max Dual Blood Glucose and Ketone Monitoring System GM771 After SSP undergoes review by the NOTIFIED BODY, a new file will be uploaded.
39 Vivora glucoDuo Blood Glucose and Ketone Monitoring System
40 RIGHTEST Wiz Blood Glucose Monitoring System

GM570
After SSP undergoes review by the NOTIFIED BODY, a new file will be uploaded.
41 GE Wiz Blood Glucose Monitoring System
42 GE GlucoCapture Wiz Blood Glucose Monitoring System
43 RIGHTEST Max Blood Glucose Monitoring System
GM770		 After SSP undergoes review by the NOTIFIED BODY, a new file will be uploaded.
44 GE Max Blood Glucose Monitoring System