All data at a glance
Download Center
Our download center provides you with the latest data sheets, brochures, and certifications for our products – compact, up-to-date and available at any time.
- EC Certificate / Directive 93/42/EEC [>> pdf]
- Notified Body Confirmation Letter [>> pdf]
- Lettre de confirmation de l’organisme notifié [>> pdf]
- Manufacturer’s Declaration [>> pdf]
- MDSAP [>> pdf]
- CeramOptec GmbH: ISO 9001:2015 [>> pdf]
(French version: ISO 9001:2015 [>> pdf]) - CeramOptec GmbH: EN ISO 13485:2016 [>> pdf]
(French version: EN ISO 13485:2016 [>> pdf]) - Ceram Optec SIA: ISO 9001:2015 [>> pdf]
- Ceram Optec SIA: EN ISO 13485:2016 [>> pdf]
- Ceram Optec SIA: ISO 14001:2015 [>> pdf]
- Ceram Optec SIA: EN ISO 11135:2014 [>> pdf]
For detailed safety and performance information concerning our medical devices, please refer to the following overview page:
Device Identification, Safety and Performance Information Brochures
