Documents

Documents & certificates

General company-level documents are listed below. Product-specific declarations, IFUs and service manuals are shared on request once we identify the exact model and serial number.

  • ISO 13485 — Quality management
    PDF · 612 KB
    Request
  • ISO 14001 — Environmental management
    PDF · 480 KB
    Request
  • CE declarations — capital equipment
    PDF · 1.2 MB
    Request
  • FDA 510(k) summaries — selected lines
    PDF · 980 KB
    Request
  • Company profile 2026
    PDF · 4.6 MB
    Request
  • Logistics & incoterms guide
    PDF · 320 KB
    Request