EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10

Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Regulation 2017/745/EU, 5 May 2017, as amended by Regulation 2020/561/EU, 24 April 2020

This list contains hazardous substances for purposes of the Medical Devices Regulation (MDR), based on the legislation's Annex I general safety and performance requirements, including for chemical, physical and biological properties. Specifically, the non-exhaustive database is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list).

sodium 2-(4-(4-fluoro-6-(2-sulfo-ethylamino)-[1,3,5]triazin-2-ylamino)-2-ureido-phenylazo)-5-(4-sulfophenylazo)benzene-1-sulfonate

FAT 40'436; FAT 40'436/A; REACTIVE ORANGE TZ 3538 EC / List no: 410-770-3 CAS no: 146177-84-6
EU CLP (1272/2008)
Skin Sens. 1