Basic Information
- Number
- ITH 2379777 1
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- October 22, 2024
- Expiry Date
- July 18, 2027
- Revision
- 2.0
- Manufacturer
- Age Solutions Srl
Certificate Lifecycle
Conditions
English
Limitations: Medical device intended to provide information to take decisions for the diagnosis and planning of orthodontic treatments and devices as listed below: • templates for the positioning of orthodontic brackets • clear aligners • bite anti-bruxism, • templates for the realization of total mobile prosthesis
Italian
Limitazioni: Dispositivo medico destinato a fornire informazioni per prendere decisioni per la diagnosi e la pianificazione dei trattamenti ortodontici e dei dispositivi elencati di seguito: • modelli per il posizionamento dei brackets ortodontici • allineatori trasparenti • bite anti-bruxismo, • modelli per la realizzazione di protesi mobili totali
Scopes
2 scopes covering 1 risk classes
Quality Procedure Scope
Software
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.