Following our recertification audit in November 2025 our latest ISO 13485:2016 certificate covering 13th March 2026 to 12th March 2029 can now be downloaded using the link below.
There is also a link to the previous revision of the certificate which was published on 7th October 2024 with an expiry of 12th March 2026.
The following information relating to Safety and Performance relevant to the user, or any other person, is supplied in accordance with the Medical Device Regulations 2017/745, Annex I General Safety And Performance Requirements, Chapter III Requirements Regarding the Information Supplied with the Device, 23.1. General requirements regarding the information supplied by the manufacturer.
Please note these may not constitute the complete user instructions for use, for full Instructions for Use please see documentation supplied with the device.
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