Certificates

ZL MICRODENT maintains a quality management system. Our company fulfils the high requirements from the quality standard for medical devices (DIN EN ISO 13485:2016). Observance of this high quality is ensured by an annual surveillance audit by the BSI Group.

Certificates:
DIN EN ISO 13485:2016

Annex V of the Directive 93/42/EEC – European Medical Devices Directive, Development and Manufacturing of Medical Devices.

Reporting to SB-MPG (Safety Officer-Medical Devices Directive)
ZL Microdent-Attachment GmbH & Co. KG develops and produces the highest quality medical products with the greatest possible care.
If there is a malfunction, breakdown, deterioration in the performance or characteristics or inadequacy in the labelling or instructions for use of a medical device, which has led to, might have led to or could lead to deterioration of the health of a user or other person, please inform us immediately:

During business hours Mo. – Fr. 8.30 – 17.00 hours: +49 (0)2338-801-0
Outside our business hours +49 (0)2338-801-58