Denas Certifications

Denas is regulated by the United States Food and Drug Administration, under 21 CFR 882.5050. Generic name: device, biofeedback, Product Code HCC, Class II exempt from 510 (k) pre-market notification according to FDA Notice FR21ja98-84 as a battery powered, professional use device for relaxation training and muscle reeducation.

	Certification DENAS - EUROCAT (English) DENAS. The certificate of conformity under Annex V to Section 3 of the Instruction 93/42/EEC about medical products. (CE-sign)
	Certification DiaDENS-T - EUROCAT (English) DiaDENS-T. The certificate of conformity under Annex V to Section 3 of the Instruction 93/42/EEC about medical products. (CE-sign)
	Certification DiaDENS-DT - EUROCAT (English) DiaDENS-DT. The certificate of conformity under Annex V to Section 3 of the Instruction 93/42/EEC about medical products. (CE-sign)
	DENAS. Certification for the Europe (English) EUROCAT The certificate on conformity of system of quality management ISO 13488:2001
	DENAS. Certification for the Europe (English) EUROCAT The certificate on conformity of system of quality management ISO 9001:2000