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This declaration is the sole responsibility of Tattoo Spray Ltd.
Tattoo Spray Ltd hereby declare that the devices described hereafter:
| Product | Description | GMDN Code | EMDN Code | Basic UDI-DI | Product UDI-DI |
|---|---|---|---|---|---|
| TS 0400 | Tattoo Spray 400ml | 62535 | M9002 | 507000305441T50J 4 | 5070003054404 |
| TS 0150 | Tattoo Spray 150ml | 62535 | M9002 | 507000305441T50J 4 | 5070003054428 |
| TS 0325 | Tattoo Spray 32.5ml | 62535 | M9002 | 507000305441T50J 4 | 5070003054411 |
have been classified as Class I (Rule 4) in accordance with Annex IX of the Medical Device Directive 93/42/EEC, and UK MDR 2002. The devices meet the essential requirements as per Annex I and are as per the conformity assessment procedure set out in Article 11. They have been manufactured under a Quality Management System based on EN ISO 13485:2016 and are in conformity with the harmonised standards ISO 15223-1:2021 and ISO 14971:2019.
A full technical file is held in accordance with our Quality Management System. The devices are also registered as Class I medical devices by Tattoo Spray Ltd with the national competent authority MHRA. The above-mentioned devices are also in conformity with the harmonised standards ISO 13485:2016, ISO 15223-1:2021 and ISO 14971:2019.
Tattoo Spray Ltd
Innsworth Tech Park, Innsworth Lane, Gloucester, GL13 1DL, UK.
The intended purpose of the Tattoo Spray: To provide a protective barrier against dirt and contaminants for tattoos to facilitate natural healing.
