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).

trisodium bis(2-(5-chloro-4-nitro-2-oxidophenylazo)-5-sulphonato-1-naphtholato)chromate(1-)

ACID BLUE 349; AZO-METALCOMPLEX-BLUE AP 1149; BLEU ACIDE 349; C.I. ACID BLUE 349; SELLASET BLEU H; SELLASET BLUE H EC / List no: 402-870-0 CAS no: 93952-24-0
EU CLP (1272/2008)
Eye Dam. 1