EUDAMED last updated this device on Mar 17, 2026
HELIOS® Automated IFA System
42502895HELIOSGROn the marketIVDR Class A
- Applicable legislation
- —
- Organization name
- Aesku.Diagnostics GmbH & Co. KG
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →- 04250289512541
- Reference / catalog number
- REF.IOS-1000
Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.
HELIOS® Automated IFA System is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Aesku.Diagnostics GmbH & Co. KG. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.