Quality
Certified, audited, traceable.
Our quality system covers every instrument from raw material to shipment.
ISO 13485:2016
Certified by TÜV AUSTRIA
CE · MDD 93/42/EEC
Class I, CNC Services
FDA Green List
Import Alert 76-01
Certificate library
Documents for your registration files.
| Document | Scope | |
|---|---|---|
| ISO 13485:2016 | Issued by TÜV AUSTRIA. Reg. no. 20105243020194/00. Valid until 23 Sep 2027. Scope: manufacture and sales of re-usable and non-sterile single use surgical instruments (invasive and non-invasive) and dental instruments. | Download PDF |
| CE certificate of compliance (MDD 93/42/EEC) | Issued by CNC Services, Germany. Certificate no. EC/3097/09. Class I, re-usable, non-powered, non-measuring surgical and dental instruments. Valid until 14 Aug 2027. | Download PDF |
| FDA Import Alert 76-01 Green List | FDA acknowledgement letter dated 2 Nov 2011 (FEI 3007773213). Copy available on request. | Request copy |