EU Authorized Representative

The EU authorized representative for Micropace as of 19th May 2026:

Advena SRL
Viale Papa Giovanni XXIII, 106
Bergamo 24121, Italy

Quality Commitment – EPS320 Cardiac Stimulator

Micropace Pty Ltd maintains its commitment to quality through the following certifications and country approvals:

• EU: Certified by BSI Group The Netherland B.V to Directive 93/42/EEC Annex II (CE2797).
• QMS: Certified by BSI Group UK to ISO 13485:2016.
• USA: 510(k) accepted by FDA, K011826, K072200 and K253088.
• Australia: ARTGs certified via EU CE Certificate/Manufacturer Evidence for compliance to Essential Requirements required by TGA.
• Japan: Accredited Manufacturer, BG60100005, products Shonin Approval No. 21900BZX00811000.