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Ergoline Ergoscan

Device Name:Ergoscan
Manufacturer:

OBL: Ergoline GmbH, Lindenstra├če 5, 72475 Bitz, GERMANY.

OEM: EnviteC-Wismar GmbH, Alter Holzhafen 18, 23966 Wismar, GERMANY.

Measuring functions:Blood pressure
Primary Client Use:Intended for ambulatory blood pressure monitoring
Measurement Site:Upper Arm
Measurement Occurrence:Intermittent measurements at specified intervals or times
Availability:Available Currently
Assessment:

While the technology used in the Ergoline Ergoscan, to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared 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)ABPMManufacturer declaration of equivalence
ESH (Europe)ABPMThe BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria.

Device Family:EnviteC PhysioQuant ABPM (45-00-0500)B, Ergoline ErgoscanB (B BIHS Derivative)
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.

EnviteC PhysioQuant ABPM (45-00-0500)

Langewitz W, Tanner S. Validation of the PhysioQuant blood pressure measuring monitor in adults. Blood Press Monit. 2009 Oct;14(5):220-1. doi: 10.1097/MBP.0b013e328330c830. PMID: 19704372.

ESH-IP:2002 - Pass General population