Approvals and regulatory

AOS Anterior Instructions for Use (IFU) & Intended use statement are available here in .pdf format.

Registrations

MHRA Registration Number – 2021032301196322

FDA Registration Number – 3014329625

India CDSCO – Registration Number: Advanc-GBR/I/MD/005674

QMS, Approvals and Regulatory information

Anterior is registered as a Class I Medical Device (rule 12 MDD) as per MEDDEV 93/42/EEC of 14 June 1993, amended by Directive 2007/47/EC and the following harmonised standards;

 

ISO 15223 -1:2016 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied

EN ISO 14971:2012 Medical Devices – Application of risk management to medical devices

BS EN 62304:2006+A1:2015 – Medical device software – Software lifecycle processes

BS EN 62366-1:2015 – Medical devices – Part 1: Application of usability engineering to medical devices

EN 1041:2008 information supplied by the manufacturer of medical devices

Authorised European Representative

European Healthcare & Device Solutions (Ireland) Ltd,

Stratton House, Bishoptown Road, Cork, Ireland T12 Y9TC