MDR MDR QMS Issued

28620117074

Manufacturer: Agfa HealthCare NV
Basic UDI-DIs
0
Scopes
3
Preceding Certs
0
Risk Classes
1
Characteristics
0
Revision
0
76
Expires in 76 days
Expiry: August 24, 2026

Basic Information

Number
28620117074
Type
MDR QMS
Legislation
MDR
Issue Date
August 25, 2021
Expiry Date
August 24, 2026
Manufacturer
Agfa HealthCare NV

Certificate Lifecycle

August 25, 2021 August 24, 2026

Scopes

3 scopes covering 1 risk classes

Quality Procedure Scope

Device Class IIa

Quality Procedure Scope

Device Class IIa

Quality Procedure Scope

Device Group Class IIa

Software for imaging, radiology and clinical information

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.