Quality & Regulatory
EU Authorized Representative
The EU authorized representative for Micropace as of 1st September 2008:
Advena Ltd, Pure Offices, Plato Close, Warwick CV34 6WE UK
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 UK to Directive 93/42/EEC Annex II (CE0086).
- 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.