alphatec-58-535w_alphatec®-58-535w_uk_20231117_declaration of conformity

1. AJKLOPT 3132A X1XXXX UK DECLARATION OF CONFORMITY declares under his sole responsibility, that the PPE described hereafter: AlphaTec 58-535W PPE to be used against category III risks The Manufacturer ANSELL HEALTHCARE EUROPE N.V. RIVERSIDE BUSINESS PARK, BLOCK J BOULEVARD INTERNATIONAL 55 B-1070 BRUSSELS BELGIUM ® is in conformity with the provisions of Regulation 2016/425 on personal protective equipment, as amended to apply in GB, and with the standards EN ISO 374-1:2016, EN ISO 21420:2020, EN ISO 374-5:2016, EN 388:2016 +A1:2018, EN407:2020 and is identical to the PPE which is subject to the UK Type-examination (Module B, Annex V of the Regulation), under certificate number AB0321/23434-01/E00-00, issued by the Approved Body: SATRA TECHNOLOGY CENTRE WYNDHAM WAY, TELFORD WAY, KETTERING, NORTHAMPTONSHIRE, NN16 8SD, UNITED KINGDOM and is subject to the conformity assessment procedure set in out in Annex VIII (Module D) of the Regulation under the surveillance of the Approved Body: SATRA TECHNOLOGY CENTRE WYNDHAM WAY, TELFORD WAY, KETTERING, NORTHAMPTONSHIRE, NN16 8SD, UNITED KINGDOM Guido Van Duren Director - Regulatory affairs Ansell Place: Brussels Date: 2023/01/18