Basic Information
- Number
- IT321284
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- February 23, 2023
- Expiry Date
- February 22, 2028
- Revision
- 2
- Manufacturer
- GPI S.P.A.
Certificate Lifecycle
Scopes
12 scopes covering 2 risk classes
Quality Procedure Scope
Quality Procedure Scope
Z12040192 - Strumentazione per monitoraggio e diagnosi in medicina generale. Z12040192 - General medicine diagnosis and monitoring instruments.
Quality Procedure Scope
Z12030292 - Strumentazione per il monitoraggio di parametri vitali - Dispositivi medici software Z12030292 - Vital signs monitoring instruments - Medical device software
Quality Procedure Scope
Z11069092 - Strumentazione varia per la gestione delle bioimmagini digitali - Dispositivi medici software Z11069092 - Various digital bioimaging management instruments - Medical device software
Quality Procedure Scope
Z121799 - Strumentazione per emotrasfusione - Altra Z121799 - Blood transfusion instruments – Others
Quality Procedure Scope
Z12040292 - Strumentazione per trattamenti terapeutici in medicina generale - dispositivi medici software Z12040292 - General medicine therapeutic treatment instruments - Medical device software
Quality Procedure Scope
Quality Procedure Scope
Quality Procedure Scope
Quality Procedure Scope
Quality Procedure Scope
Quality Procedure Scope
Preceding Certificates
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.