Device Name:
Fora
Device Model:
GD40
Manufacturer:
OBL: ForaCare Japan Co. Ltd., 3rd floor, FORA Building, 5-10-8 Shinbashi, Minato-ku, Tokyo 105-0004, JAPAN.
OEM: TaiDoc Technology Corporation, 6F - 127 Wugong 2nd Road, 24888 Wugu District, New Taipei City, TAIWAN ROC.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
United Arab Emirates and Japan
Description:
The Fora GD40 is an automatic blood glucose meter. The accuracy of its blood glucose measurement technology has yet to be proven to MDR requirements. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.
Assessment:
There appears to be no peer-reviewed clinical validation information available on the technology used in the Fora GD40 to measure blood glucose. However, this device appears to be very similar to a validated device by the same manufacturer or a device within a family of equivalent devices, but equivalence needs to be proven according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
| Accuracy Assessment | Recommendation | Basis |
| BG |
Medaval |
None |
Although equivalence to another device is claimed, this has not been tested to MDR requirements. |
Device Family:
Validation Publications for Equivalent Devices:
Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.
Fora Comfort Pro (GD40b, TD-4272B)
Yu-Fei W, Wei-Ping J, Ming-Hsun W, Miao-O C, Ming-Chang H, Chi-Pin W, Ming-Shih L. Accuracy Evaluation of 19 Blood Glucose Monitoring Systems Manufactured in the Asia-Pacific Region: A Multicenter Study. J Diabetes Sci Technol. 2017 Sep;11(5):953-65. Epub: 2017 May 8. doi: 10.1177/1932296817705143. PMID: 28480733. Available from: PMC5950995.
15197:2013 - Pass General population
15197:2003 - Pass General population
