• Regulation 2017/745 MDR and subsequent amendments. • EC certificate No. 0425-MDR-030019-00 • Declaration of Conformity dated 15.02.2023 • UNI CEI EN ISO 13485 -2012 (registered No. 3127-M) • European Pharmacopeia • ISO 594-1, 594-2, ISO 8536/4 • ISO 11737-1 • Assembled in class 100000 – ISO8 clean room • EO residual in conformity with E. Pharm. ≤10 ppm