Aponorm Mobil Slim 3G

Device Name:

Mobil Slim 3G

Manufacturer:

OBL: WEPA Apothekenbedarf GmbH & Co KG (Aponorm), Am Fichtenstrauch 6-10, 56204 Hillscheid, GERMANY.

OEM: 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:

Wrist

Measurement Occurrence:

Single measurements only

Availability:

Available Currently

Availability according to Countries or Regions:

Germany

Device Manual:

Click here to download the Device Manual

Description:

The Aponorm Mobil Slim 3G 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 wrist. It is intended for self-measurement and home use.

Assessment:

While the technology used in the Aponorm Mobil Slim 3G, to measure blood pressure, has been assessed, the results of the study have not been published and cannot be verified. It has also 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BP	DHL (DE)	General use (Latest: 2017)	Unpublished internal data
BP	Stride BP	Self-measurement for adults	Equivalence claim without published evidence

	Consumer Body	Year(s)	Level	Comment
BP	Stiftung Warentest (DE)	Previous: 2018	Adequate

Device Family:

Aponorm Mobil Slim 3GP, Microlife BP W2 SlimP, Microlife BP W3 Comfort (BP 3KB1-3E)P
Legend: P Stride Equivalence

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 W2 Slim

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