All medical devices are regulated by European Directive 93/42/EEC.

According to certain criteria of classification of products, these must meet a series of requirements. All health Tedisel Medical products are developed and manufactured according to the criteria set by this directive.

Likewise, the company and its management system is certified with the seal of quality EN ISO 9001 and EN ISO 13485:2012.
The design, functionality and quality must not be incompatible with the safety of patients and users. Ask for the certificates.


CE
Health licence
Tuv R EN ISO 13485 2012
Tuv R 9001 2008
health-licence-licencia-sanitaria
Certificate-ISO9001-english-I
Certificate-ISO9001-english-II
Certificate-ISO13485-english

SICA family

Declaration of Conformity_SICA

SICS family

Declaration of Conformity_SICS

UMOS family

Declaration of Conformity_UMOS

Q-Panel family

Declaration of Conformity_Q-Panel

ES340 family

Declaration of Conformity_ES340

Kalea family

Declaration of Conformity_Kalea Surgical Lights (Surgiris)