MDR MDR QMS Issued

FI24/0000001

Basic UDI-DIs
0
Scopes
4
Preceding Certs
0
Risk Classes
1
Characteristics
0
Revision
Issue 1
946
Valid for 946 days
Expiry: January 9, 2029

Basic Information

Number
FI24/0000001
Type
MDR QMS
Legislation
MDR
Issue Date
January 10, 2024
Expiry Date
January 9, 2029
Revision
Issue 1

Certificate Lifecycle

January 10, 2024 January 9, 2029

Scopes

4 scopes covering 1 risk classes

Quality Procedure Scope

Device Class IIb

Quality Procedure Scope

Device Class IIb

Quality Procedure Scope

Device Class IIb

Quality Procedure Scope

Device Group Class IIb

EMDN Z11031101 Multifunctional Systems for Direct Digital Radiology

Basic UDI-DIs

This Certificate doesn't seem to be associated with any Basic UDI-DIs. If you think that sounds weird, so do we. But that's what the EUDAMED data seems to state.