SurgicEye

Certificates

SurgicEye maintains the highest quality for all services, solutions, products, and processes. The high quality is the intrinsic philosophy of all actions performed by SurgicEye, its team, and selected partners.

The most relevant certificates are available for download the relevant SurgicEye certificates. For further certificates, information and questions regarding SurgicEye's quality philosophy, quality management and regulatory affairs, please contact our quality management department at This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

Quality Management System EN ISO 13485 : 2003 + AC 2007

EN ISO 13485 : 2003 + AC : 2007

Product Certificate for declipse®SPECT

CE Certificate - Annex II - Selection 3 of Council Directive 93/42/EEC concerning medical devices

FDA 510(K) Summary

Product Certificate for declipse®SPECT laparoscopic

CE Certificate - Annex II - Selection 3 of Council Directive 93/42/EEC concerning medical devices

FDA 510(K) Summary

News

Hybrid and mobile SPECT⁄Ultrasound imaging proposes a non-surgical procedure for sentinel lymph node biopsy

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Events