Quality & Regulatory

EU Authorized Representative

The EU authorized representative for Micropace as of 1st February 2021:

Advena Ltd
Tower Business Centre, 2nd Floor,
Tower Street, Swatar, BKR 4013 – Malta

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 and K072200.
  • Australia: ARTGs certified via EU CE Certificate/Manufacturer Evidence for compliance to Esstential requirements required by TGA.
  • Japan: Accredited Manufacturer, BG60100005, products Shonin Approval No. 21900BZX00811000.

Quality Policy