Certifications And Logos; European Registration - Hettich Rotina 420 R Mode D'emploi

Device overview
3.2

Certifications and logos

Certifications
EN ISO 13485
Quality management in accordance with ISO 13485
Logos
Made in Germany
Device was developed and made in Germany.
3.3

European registration

Device conformity
Single Registration Number
Basic-UDI-DI
14 / 64
ISO 9001
Quality management system in accordance with
ISO 9001
ISO 14001
Environmental management in accordance with
ISO 14001
Device conformity according to EU directives.
SRN: DE-MF-000010680
Basic-UDI-DI
040506740100159V
Rev.: 19 / 02.2025
Device assignment
ROTINA 420 / 420 R (in vitro diagnostic
medical device)
AB4701en