![](/images/devices/Foracare/GD40.jpg)
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.
Accuracy Assessment | Recommendation | Basis | |
BG | Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. |
Legend: Z Almost Certain
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