MDR MDR QMS Issued

ITH 1343191 1

Manufacturer: CARDIOLINE
Basic UDI-DIs
0
Scopes
2
Preceding Certs
0
Risk Classes
1
Characteristics
0
Revision
1.0

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1181
Valid for 1181 days
Expiry: October 20, 2029

Basic Information

Number
ITH 1343191 1
Type
MDR QMS
Legislation
MDR
Issue Date
October 21, 2024
Expiry Date
October 20, 2029
Revision
1.0
Manufacturer
CARDIOLINE

Certificate Lifecycle

October 21, 2024 October 20, 2029

Scopes

2 scopes covering 1 risk classes

Quality Procedure Scope

Device Group Class IIa

Software

Quality Procedure Scope

Device Group Class IIa

Dispositivi non impiantabili attivi per il monitoraggio dei parametri fisiologici vitali / Active non-implantable devices for monitoring of vital physiological parameters

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.