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).

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tetrasodium 4-amino-3,6-bis(5-(6-chloro-4-(2-hydroxyethylamino)-1,3,5-triazin-2-ylamino)-2-sulfonatophenylazo)-5-hydroxynaphthalene-2,7-sulfonate (containing > 35 % sodium chloride and sodium acetate)

BLEU MARINE DRIMARENE X-GN PKT; BLEU MARINE X-VT 4046; DRIMAREN MARINEBLAU X-GN PKT; DRIMAREN NAVY X-GN PKT; NAVY BLUE X-VT 4046 EC / List no: 400-510-7 CAS no: 85665-98-1
EU CLP (1272/2008)
Eye Dam. 1; Skin Sens. 1