This declaration is the sole responsibility of Tattoo Spray Ltd.
This declaration is made under Annex IV of the Medical Device Regulation 2017/745.
| Product Description | GMDN Code | EMDN Code | Basic UDI-DI | Product UDI-DI |
|---|---|---|---|---|
| TS 0400 Tattoo Spray 400ml | 62535 | M9002 | 50700030544TS0J4 | 5070003054404 |
| TS 0150 Tattoo Spray 150ml | 62535 | M9002 | 50700030544TS0J4 | 5070003054428 |
| TS 0325 Tattoo Spray 32.5ml | 62535 | M9002 | 50700030544TS0J4 | 5070003054411 |
Tattoo Spray Ltd hereby declares that the medical devices stated within this document comply with the requirements of the Medical Device Regulation 2017/745 in accordance with Annex VIII and are classified as Class I (Rule 4). The mentioned devices are in conformity with the regulation MDR 2017/745.
The devices meet the general safety and performance requirements as per Annex I and have been assessed as per the conformity assessment procedure set out in Annex IX.
A full technical file is held in based on a Quality Management System which follows ISO13485:2016. The devices are also registered as Class I medical devices by Tattoo Spray Ltd with the national competent authority MHRA and registered by our EU Authorised Representative with the MMA. The above-mentioned devices are also in conformity with the harmonised standards ISO 13485:2016, ISO 15223-1:2021 and ISO 14971:2019.
This declaration of Tattoo Spray Ltd is supported by a quality management system based upon ISO 13485:2016.
Devices manufactured by Tattoo Spray Ltd, Innsworth Tech Park, Innsworth Lane, Gloucester, GL13 1DL, UK with EU Authorised Representative Advena Ltd, Tower Business Centre, 2nd Flr, Tower Street, Swatar, BKR 4013, Malta (SRN MT-AR-000000234).
The intended purpose of the Tattoo Spray: To provide a protective barrier against dirt and contaminates for tattoos to facilitate natural healing.
