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 (2-((3-(6-(2-chloro-5-sulfonato)anilino)-4-(3-carboxypyridinio)-1,3,5-triazin-2-ylamino)-2-oxido-5-sulfonatophenylazo)phenylmethylazo)-4-sulfonatobenzoato)copper(3-)) hydroxide

C.I. REAKTIV-BLAU 216; KAYACELON REACT BLUE CN-BL; KAYACELON REAKT-BLAU CN-BL; UBCNBL EC / List no: 404-670-9 CAS no: 89797-01-3
EU CLP (1272/2008)
Skin Sens. 1