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Novama Comfort+ AF (BP 68)
Device Name:
Comfort+ AF
Device Model:
BP 68
Manufacturer:

OBL: Novama.Tech sp. z o.o. (Novama), ul. Traktorowa 196, 91-218 Łódź, POLAND.

OEM: AViTA Corporation, 9F No. 78 Sec 1, Gwang-Fu Road, Sanchong Dist., New Taipei City 24158, TAIWAN ROC.

Measuring functions:
Blood Pressure and PR
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Novama Comfort+ AF (BP 68) 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 Novama Comfort+ AF (BP 68), 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 Stride BP Self-measurement for adults (Preferred) Equivalence to the AViTA BPM68 claim without published evidence
Device Family:
AViTA BPM64 (V1)P, AViTA BPM64 (V2)P, AViTA BPM68P, AViTA BPM82P, AViTA BPM83P, AViTA BPM925-LJBP, Novama Comfort+ AF (BP 68)P, Novama First+ (V2)P, Novama Prime (BPM83)Z, Novama Prime+ (BPM83)P, Novama Pro BlueP, Novama White M (BPM82)Z, Novama White M+ (BPM82)Z, Novama BP
Legend: 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.

AViTA BPM64 (V1)

Kang YY, Chen Q, Liu CY, Li Y, Wang JG. Validation of the AVITA BPM64 upper-arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2018 Feb;23(1):45-8. Epub: 2017 Oct 18. doi: 10.1097/MBP.0000000000000296. PMID: 29049094.

ESH-IP:2010 - Pass General population

AViTA BPM82

Menti A, Ntousopoulos V, Theodosiadi A, Stathopoulou P, Kollias A, Stergiou GS. Validation of the automated oscillometric upper-arm cuff home blood pressure monitor AVITA BPM82 in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard. Blood Press Monit. 2024 Apr 1;29(2):89-92. Epub: 2023 Nov 6. doi: 10.1097/MBP.0000000000000682. PMID: 37937605.

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

Menti A, Lempidaki P, Mariglis D, Antonogiannaki EC, Bakalakou KR, Komnianou A, Kollias A, Stergiou GS. Validation of the automated oscillometric home blood pressure monitor AViTA BPM82 in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018). Blood Press Monit. Epub: 2026 Feb 2. doi: 10.1097/MBP.0000000000000795. PMID: 41670419.

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

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