Basic Information
- Number
- ITH 2477191 1
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- December 10, 2024
- Expiry Date
- February 28, 2029
- Revision
- 4.0
- Manufacturer
- Bonebridge AG
Certificate Lifecycle
Device Characteristics
Conditions
English
The scope of certification is limited to the aspects relating to the conformity of the devices with the metrological requirements The scope of certification is limited to the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use
Italian
Lo scopo della certificazione è limitato agli aspetti che riguardano la conformità dei dispositivi ai requisiti metrologici Lo scopo della certificazione è limitato agli aspetti relativi al riutilizzo del dispositivo, in particolare a pulizia, disinfezione, sterilizzazione, manutenzione, test funzionale e relative istruzioni per l'uso
Scopes
2 scopes covering 3 risk classes
Quality Procedure Scope
Impianti ossei e ortopedici non attivi / Nonactive osteo- and orthopaedic implants
Quality Procedure Scope
Strumenti non impiantabili non attivi / Non-active nonimplantable instruments
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.