EuroMedix Stabil-O-Graph
Device Name:
Stabil-O-Graph
Manufacturer:
OBL: EuroMedix POC nv/sa, Vaartdijk 59, B-3018 Leuven (Wijgmaal), BELGIUM.
OEM: Industrielle Entwicklung Medizintechnik und Vertriebsgesellschaft GmbH (IEM), Cockerillstraße 69, D-52222 Stolberg, GERMANY.
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 EuroMedix Stabil-O-Graph 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 professional use.
Assessment:
Medaval is in the process of checking the validation status of this device.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | None | While a clinical validation is claimed, it cannot be checked properly. |
| BP | BIHS (UK and IRL) | Self-measurement (Previous) | Published evidence |