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Regulatory Compliance 

ZedView 2.5D & 3D

EC Certificate

【EC Certificate】

No. G1 086715 0010 Rev .00
Valid from: 2019-09-02
Valid until: 2024-05-26

ISO 13485 Certificate

【ISO 13485 Certificate】

 

No. Q5 086715 0009 Rev. 00

Applied Standard: EN ISO 13485:2016

Valid from: 2019-01-22

Valid until: 2020-09-01

FDA 510(k)

510(k) clearance for ZedView has been granted by the FDA.

2019 by LEXI Europe GmbH

all rights reserved to their respective owners

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Gruendlacher Strasse 304 - 90765 Fürth (Germany)

Tel: +49 911 148 861 03