Declaration of Conformity
Vertidisan is a CE-marked medical device pursuant to the EU MDR (2017/745).
Translation of the original document
EU Declaration of Conformity
pursuant to Article 19, Regulation (EU) 2017/745 (MDR)
August-Bebel-Str. 9
72072 Tübingen, Germany
Tel.: +49-7071 793-6192
E-Mail: office@digitineers.com
SRN: DE-MF-000006403
This declaration of conformity is issued under the sole responsibility of the manufacturer.
Product Designation
| Product name: | Verti-HApp |
| Trade name: | Vertidisan® |
| Product code: | VH-90-D / Version 1.0.2 D |
Intended Purpose
Verti-HApp serves to improve vertigo in peripheral balance disorders. Verti-HApp further serves to document manually entered health data and to forward that documentation. Verti-HApp does not serve to produce or provide information for use in diagnostic or therapeutic decisions.
Identification
| Basic UDI-DI (Annex VI Part C): | 42700027834VH90-DN6 |
| Risk class under MDR (2017), Annex VIII: | Class I (one) |
We confirm that the product conforms to the applicable general safety and performance requirements pursuant to the Medical Device Regulation (EU) 2017/745.
Place, Date
Tübingen, 19 September 2022
Signatory
Prof. Dr. H.P. Zenner
Managing Partner
Digitineers GmbH & Co. KG