High quality and the satisfaction of our clients are guaranteed by our quality assurance certifications: ISO 9001 and ISO 13485. All our products are CE marked in line with the relevant EU Medical Devices Directive 93/42/EEC.

CE   ISO 13485 SGS LOGO

The ECG Holters have received the US FDA 510(k) clearance under the number K140847.

Our products are licensed in Canada under CMDA License Number 92271.