Nuance Audio

Nom de l'organisation

Luxottica Group S.p.A

SRN

IT-MF-000041132

Statut du fabricant

Actif

7 avertissements enregistrés — faire défiler le panneau pour tout voir.

• CW275

  The Nuance Audio ™ Glasses and the Charging Pad contain magnetic material and components that emit radio waves, which could affect the operation of medical devices such as but not limited to pacemakers or insulin pumps, or other implantable devices, consult your doctor or the medical device manufacturer before using the Nuance Audio ™ Glasses and the Charging Pad.
• CW023

  Don’t near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high.
• CW018

  EUDAMED n'a pas publié de description pour ce code.
• CW030

  If you have any of the problems listed below, please see a healthcare professional. • Your ear has a birth defect or an unusual shape. Your ear was injured or deformed in an accident. • You saw blood, pus or fluid coming out of your ear within the past 6 months. • Your ear feels painful or uncomfortable • You have a lot of earwax or you think something could be in your ear • You get dizzy or have a feeling of spinning or swaying (called vertigo) • Your hearing changed suddenly in the past 6 months • Your hearing changes: it gets worse then gets better again • You have worse hearing in one ear • You hear ringing or buzzing in only one ear.
• CW024

  Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
• CW027

  EUDAMED n'a pas publié de description pour ce code.
• CW262

  EUDAMED n'a pas publié de description pour ce code.

Marché principal en Italie ; disponible dans 32 pays au total.

Dénomination commerciale

Nuance Audio

Code d'UDI-DI

08059820279808

Basic UDI-DI

8056597000000Y214506CB0CN

Numéro de référence/catalogue

AW5002748

Entité d'attribution

GS1

Catégorie de risque

Classe IIa

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

—

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

• 48 MU50

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• Y2145060101BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)