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Braun ExactFit 3 (BP-6100)

Device Name:ExactFit 3
Device Model:BP-6100
Manufacturer:

OBL: B. Braun Melsungen AG, Carl-Braun-Stra├če, 134212 Melsungen, GERMANY.

OEM: Guangdong Transtek Medical Electronics Co. Ltd., Zone A, 105 Dongli Road, Torch Development District, Zhongshan 528437, CHINA.

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
Assessment:

The technology used in the Braun ExactFit 3 (BP-6100), to measure blood pressure, has been compared to a clinically validated device but not according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
BIHS (UK and IRL)Self-measurementManufacturer declaration of equivalence
ESH (Europe)Self-measurementPublished evidence

Device Family:Braun ExactFit 3 (BP-6000)B,D, Braun ExactFit 3 (BP-6100)B,D, Braun ExactFit 5 (BP-6200)B,D, HoMedics BPA-2000-EUB, HoMedics BPA-3000-EUB, Transtek TMB-986B,D (B BIHS Derivative, D DET 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.

Transtek TMB-986

Liu WJ, Li SG, Song Z, Gong W. Validation of the TRANSTEK blood pressure monitor TMB-986 for home blood pressure monitoring according to the International Protocol. Blood Press Monit. 2010 Oct;15(5):278-80. doi: 10.1097/MBP.0b013e32833e43ca. PMID: 20729726.

ESH-IP:2002 - Pass General population