CE Mark (EU MDR 2017/745)
- Scope
- Classes I and IIa hand instruments per Annex VIII EU MDR 2017/745.
- Issued
- 2024-09-15
- Valid until
- 2029-09-14
Quality & Certifications
Every Rubassz instrument is produced under documented quality systems. Our certifications are listed below — ask us for copies when you place an order.
ISO 13485:2016 — Medical Device Quality Management
- Scope
- Design and manufacture of stainless-steel dental hand instruments.
- Issued
- 2024-06-01
- Valid until
- 2027-05-31
Warranty & guarantee
Our instruments are inspected before shipping and backed by a replacement guarantee on manufacturing defects. See our warranty page for details.
Read the warranty →