MDR MDR QMS Supplemented

ITH 2379777 1

Manufacturer: Age Solutions Srl
Basic UDI-DIs
0
Scopes
2
Preceding Certs
1
Risk Classes
1
Characteristics
0
Revision
2.0

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356
Valid for 356 days
Expiry: July 18, 2027

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

October 22, 2024 July 18, 2027

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

Device Group Class IIa

Software

Quality Procedure Scope

Device Class IIa

Preceding Certificates

ITH 2379777 1 Issued
Issued: July 19, 2022 Expires: July 18, 2027

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.