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Certified Management Systems
Management Systems
EN ISO 13485 and MDR Ann. IX, Chapt I
Certificate Holder
Floy GmbH
Test Mark Number
9000019919
The certificate holder's Management System corresponds to standards:
EN ISO 13485
MDR Ann. IX, Chapt I
Certificate scopes
EN ISO 13485
Design, development, manufacturing, distribution, installation and servicing of software to provide information and diagnostic support in MRI medical images.
MDR Ann. IX, Chapt I
Products of Class llb:
Z110390 - DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY INSTRUMENTS
VARIOUS INSTRUMENTS FOR RADIODIAGNOSTICS AND INTERVENTIONAL PROCEDURES
