Declaration of Conformity

TATTOO SPRAY LTD
Declares that the medical device described hereafter

TATTOO SPRAY® (registered Trade Mark No: UK00003948116)

Has been classified as Class I (Annex IX Rule 4) and are in conformity with the essential requirements and provisions of Council Directive 93/42/EEC as amended by Directive 2007/47/EC and are in conformity with the national standards transposing harmonised standards BS EN ISO 14971:2012, BS EN ISO 15223-1, and BS EN ISO 13485:2012.

Under Rule 4, the product is intended to be used as a mechanical barrier for absorption of exudates when in contact with injured skin.

The device is therefore defined as Class I. and are subject to the procedure set out in Annex V of the Directive 93/42/EEC as amended
by Directive 2007/47/EC .