Edan SA-20
Device Model:
SA-20
Manufacturer:
Edan Instruments Inc., No. 15 Jinhui Rd., Jinsha Community, Kengzi Subdistrict, Pingshan District, 518122 Shenzhen, CHINA.
Measuring functions:
Blood Pressure, PR and ECG
Primary Client Use:
Intended for ambulatory blood pressure monitoring
Measurement Site:
Upper Arm
Availability:
Available Currently
Description:
The Edan SA-20 is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for ambulatory blood pressure monitoring.
Assessment:
The technology used in the Edan SA-20, to measure blood pressure, has been compared to a clinically validated device, but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. |
| BP | Stride BP | ABPM for adults (Preferred) | Equivalence to the EDAN SA-10 claim without published evidence |
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.
Edan SA-10
Wang B, Liu K, Li L, Yin S, Ren J. Validation of the EDAN SA-10 ambulatory blood pressure monitor in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard. Blood Press Monit. 2022 Aug 1;27(4):276-279. Epub: 2022 Apr 18. doi: 10.1097/MBP.0000000000000600. PMID: 35438083.
81060-2:2018 - Pass General population