ABN Regal (AS-081R)

Device Name:

Regal

Device Model:

AS-081R-D (Desktop), AS-081R-W (Wall), AS-081R-M (Mobile) (Plus -LF if Latex free)

Manufacturer:

ABN Medical, Ji Tembokan RT 01/01, DS Cipeundear Padalarang, 40553, INDONESIA.

Measuring functions:

Blood pressure

Primary Client Use:

Intended for professional use

Measurement Site:

Upper Arm

Measurement Occurrence:

Single measurements only

Availability:

Available Currently

Description:

The ABN Regal (AS-081R) is a desk (tabletop), mobile (floor, stand, trolly) or wall-mounted manually-operated aneroid sphygmomanometer. Blood pressure measurements are taken from the upper arm. It is intended for professional use.

Assessment:

There appears to be no peer-reviewed clinical validation information available on the technology used in the ABN Regal (AS-081R) to measure blood pressure. However, this device appears to be very similar to another device by the same manufacturer or a device within a family of equivalent devices. At least one validation needs to be published and equivalence needs to be proven according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	This is a manual device.

Device Family:

ABN Clock (Desktop) (AS-081D)Z, ABN Clock (Mobile) (AS-081M)Z, ABN Clock (Wall) (AS-081W)Z, ABN Regal (AS-081R)Z
Legend: Z Almost Certain