Basic Information
- Number
- ITD 2423536 1
- Type
- MDR QA
- Legislation
- MDR
- Issue Date
- October 30, 2024
- Expiry Date
- March 17, 2029
- Revision
- 4.0
- Manufacturer
- Sidam S.R.L.
Certificate Lifecycle
Device Characteristics
Scopes
4 scopes covering 2 risk classes
Quality Procedure Scope
Dispositivi non impiantabili non attivi per la somministrazione la canalizzazione e la sottrazione di sostanze, compresi i dispositivi per dialisi / Non-active non-impantable devices for administration, channeling and removal of substances, including devices for dialysis
Quality Procedure Scope
Altri dispositivi non impiantabili attivi per uso chirurgico / Other active nonimplantable surgical devices
Quality Procedure Scope
Altri dispositivi non impiantabili attivi per monitoraggio e/o diagnosi / Other active nonimplantable devices for monitoring and/or diagnosis
Quality Procedure Scope
Dispositivi non impiantabili non attivi per anestesia, pronto soccorso e terapia intensiva/ Non-active non-implantable devices for anaesthesia, emergency and intensive care
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.