Microlife BP A200 (BP 3MS1-4K)
Device Name:
BP A200
Device Model:
BP 3MS1-4K
Manufacturer:
Microlife Corporation, 9F - 431 RuiGuang Road, NeiHu, Taipei 11492, TAIWAN ROC.
Measuring functions:
Blood pressure, Arrhythmias
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Discontinued but still available
Device Manual:
Description:
The Microlife BP A200 (BP 3MS1-4K) 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 self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:
While the technology used in the Microlife BP A200 (BP 3MS1-4K), to measure blood pressure, has been declared as being equivalent to that used in another device, not only has no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4, but the results of the assessment on which the declaration has been based have not been published either and cannot be verified. However, there are validation studies proving clinical validation of the same measurement technology, according to other equivalence claims.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. |
| BP | BIHS (UK and IRL) | Previous recommendation, now removed (Previous) | Implied equivalence to the Microlife BP A200 Comfort |
| BP | ESH (Europe) | Self-measurement | The BIHS recommendation, despite the absence, at the time, of the scientific evidence required by the same authors' criteria. |
Device Family:
Microlife BP A200 (BP 3MS1-4K)B, Microlife BP A200 Comfort (BP 3MS1-4A)B,P,F, Microlife BP A3L Comfort (BP 3GX1-3A, A3L-IMT)P
Legend: B BIHS Derivative, P Stride Equivalence, F FDA 510(k)
Legend: B BIHS Derivative, P Stride Equivalence, F FDA 510(k)
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.
Microlife BP A200 Comfort (BP 3MS1-4A)
Bing S, Chen K, Hou H, Zhang W, Li L, Wei J, Shu C, Wan Y. Validation of the Microlife BP A200 Comfort and W2 Slim automated blood pressure monitors in a general adult population according to the European Society of Hypertension and the ANSI/AAMI/ISO 81060-2: 2013 protocols. Blood Press Monit. 2016 Apr;21(2):118-23. Epub: 2015 Dec. doi: 10.1097/MBP.0000000000000169. PMID: 26683381.
ESH-IP:2010 - Pass General population
81060-2:2013 - Pass General population