Aponorm Professional Control 4G
Device Name:
Professional 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, PR and Atrial fibrillation
Primary Client Use:
Intended for professional use with atrial fibrillation detection
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
Germany
Description:
The Aponorm Professional 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. With atrial fibrillation detection, it is intended for professional use.
Assessment:
The technology used in the Aponorm Professional 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 AssessmentRecommendationBasis
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 to the Microlife BP B3 AFib (BP 3KT1-3N) claim without published evidence
Device Family:
Aponorm Basis Control 4GP, Aponorm Basis Control Plus 4GP, Aponorm Professional Control 4GP, Aponorm Basis Control Plus Bluetooth 4GZ, 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 ConnectP, Microlife BP B1 Standard (BP HJA2-0)P, Microlife BP B4 BT (BP HJB2-D)P
Legend: B BIHS Derivative, P Stride Equivalence, Z Almost Certain
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.

81060-2:2018 - Pass General population

Microlife BP B6 Connect (BP 3KV1-5X)

Menti A, Ntousopoulos V, Lempidaki P, Bakalakou KR, Komnianou A, Mariglis D, Ntaskagianni E, Kollias A, Stergiou GS. Validation of the automated oscillometric upper-arm cuff home blood pressure monitor Microlife BP3KV1-5X (BP B6 Connect) in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard (ISO 81060-2:2018). Blood Press Monit. Epub: 2025 Sep 10. doi: 10.1097/MBP.0000000000000771. PMID: 40931782.

81060-2:2018/Amd 1:2020/Amd 2:2024 - Pass General population

© Medaval Ltd. Please read the Terms and Conditions before using this site.