Quality and safety

Product is CE marked.

Product has prestigious international medical certificate:"TUV, GM"/"Certificate No. I 60004482"

Product has been approved by: COTM / Warsaw nr 32386169.

Device is fully compliable to: EN 1985:1998, EN 12182:1999, EN ISO 111991:1999, PN-EN ISO 109931, ISO 14971, EN 1282, EN 1985:1999, PrPNEN 1441, PNEN 1041, PN-EN 10211, Medical Directive no 93/42. Product tested according to PrPN-EN 540-compliable to EN 540:1993 (UE, CEN: rue de Stassart, 36: B-1050 Bruxelles, Belgium).

Production compliable to ISO TC 194/WG and ISO CD 10993-8 N. Leading standard: EN ISO 111991:1999.