Device Name:
Basis Control 4G
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
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
Germany
Device Manual:
Description:
The Aponorm Basis Control 4G 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.
Assessment:
The technology used in the Aponorm Basis Control 4G, 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 |
DHL (DE) |
General use (Latest: 2019) |
Manufacturer declaration of equivalence |
| BP |
Stride BP |
Self-measurement for adults (Preferred) |
Equivalence claim without published evidence |
Device Family:
Aponorm Basis Control 4GP,
Aponorm Basis Control Plus 4GP,
Aponorm Professional Control 4GP,
Microlife BP B2 Basic (BP 3KA1-3N)B,P,
Microlife BP B2 Easy (BP 3KA1-1E)P,
Microlife BP B3 AFib (BP 3KT1-3N)B,P,
Microlife BP B6 Connect (BP 3KV1-5X)P,
Microlife BP B1 ClassicB,P,
Microlife BP B3 BT (BP 3KT1-4B)P,
Microlife BP B3 AFib AdvancedP,
Microlife BP B3 Basic (BP 3KT1-3F)P,
Microlife BP B3 Plus (BP 3KT1-4F)P,
Microlife BP B6 BasicP,
Microlife BP B6 Advanced ConnectPLegend:
B BIHS Derivative,
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 B3 AFib (BP 3KT1-3N)
Beime B, Bramlage C, Krüger R, Deutsch C, van Mark G, Bramlage P, Botta B. Validation of the Microlife BP B3 AFIB upper arm blood pressure monitor in adults and adolescents according to the ANSI/AAMI/ISO 81060-2: 2019 protocol. Blood Press Monit. 2021 Aug 1;26(4):299-304. Epub: 2021 Mar 15. doi: 10.1097/MBP.0000000000000530. PMID: 33734119.
81060-2:2019 - Pass General population
