PRODUCT NAME
Pro1 floor stand
APPLICATION
Accessory to be used with Bioptron Pro 1
PRODUCER
BIOPTRON AG - Sihleggstrasse 23, CH-8832 Wollerau - Switzerland
CERTIFICATIONS/DECLARATION
* Declaration of Conformity with the medical Directive 93/42 / EEC issued by the producer. *Confirmation of application a medical device in the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products * CE conformity for electrical equipment. * Certificate for Quality Assurance (EN ISO 13485) * Certificate for the Quality Assurance System (Directive 93/42 / EEC) issued by the FDA * DEKRA Certificate for quality control EN ISO 13485:2012 + AC:2012 * DEKRA Certificate for medical devices complying with Annex II, Section 3 of Directive 93/42 / EEC - (Notified Body ID 0124) * Declaration of conformity from DEKRA (European notified body) for all products issued in 2013 (07.21.2013)