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Clinical Validation

Many of our blood glucose monitoring system and blood pressure monitoring system are clinically validated. A symbol placed next to the product is used to indicate the validation protocol and the researcher who participated in the study. An overview of all current and relevant validations of blood glucose monitoring system and blood pressure monitoring system is provided to help you find the information you need.

As FORA strives for continued excellence in clinical competency, some of our blood glucose monitoring systems meet the emerging needs of higher accuracy in blood glucose measurement and the new ISO criteria of ± 15%.

A printable version of the overview of blood glucose monitoring system is available to show you the test results of each of the clinical validation conducted.

Clinical Validation List

Blood Glucose Monitoring System Number of Validations
FORA Diamond PRIMA (DM10) Single Validation
FORA Diamond VOICE (DM20) Single Validation
FORA Diamond MINI (DM30) Single Validation
FORA GD20 Single Validation
FORA COMFORT pro GD40 Single Validation
FORA COMFORT lux GD50 Two Validations
FORA G10 Single Validation
FORA G11 Single Validation
FORA G12 Single Validation
FORA COMFORT basic G20 Two Validations
FORA COMFORT plus G30a Four Validations
FORA COMFORT advance G31a Three Validations
FORA COMFORT advance G31b Three Validations
FORA COMFORT basic mini G70 Single Validation
FORA COMFORT plus mini G71a Three Validations
FORA COMFORT basic voice V10 Two Validations
FORA V11 Single Validation
FORA V12 Single Validation
FORA V30 Three Validations
FORA S10a Single Validation

* Declaration of Equivalence

Number of Validations Blood Glucose / Blood Pressure 2-in-1
Monitoring System
ESH 2002 ESH 2010 Dabl
1 FORA D30 PASS   Recommended
1 FORA D40b   PASS Recommended

Clinically Validated in Germany

FORA Blood Glucose Monitors are validated according to ISO 15197 requirements at an internationally renowned diabetes institute in Ulm, Germany.

Malmö University

FORA Blood Glucose Monitors are validated according to ISO 15197 requirements by Professor Nilsson at the Malmö University in Sweden.

European Society of Hypertension

FORA Blood Glucose and Blood Pressure 2-in-1 monitors are successfully validated according to the International Protocol of the ESH (European Society of Hypertension).

Agence française de sécurité sanitaire des produits de santé
French Health Products Safety Agency (Afssaps)

FORA Blood Glucose Monitors are validated according to ISO 15197 requirements by the French Health Products Safety Agency (Afssaps)

 

 
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