EU2

Nom de l'organisation

Neuromod Devices Limited

SRN

IE-MF-000004261

Statut du fabricant

Actif

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

• CW999

  Headaches may accompany use of the treatment device.
• CW999

  Caution! – Do not use the device if: You have lesions, sores, or inflammation of the oral cavity, unless directed by a doctor.
• CW999

  Caution! – Do not use the device if: You have a pacemaker, defibrillator or any other active implantable device, unless directed by a doctor.
• CW999

  Caution! – Do not use the device if: You suffer from any condition that causes impaired sensitivity of the tongue.
• CW999

  You suffer from epilepsy or any other condition that may result in loss of consciousness.
• CW999

  Contact between the Tonguetip and dental retainers or metal fillings may cause temporary discomfort.
• CW999

  There is a possibility that some people may experience a mild allergic reaction to the materials in the device.
• CW999

  You may experience a mild numbing sensation or a discomfort on the tongue during treatment. If this occurs, reduce the tongue stimulation. If the symptoms persist, contact your prescribing healthcare professional.
• CW999

  Use of the treatment may result in mild fluctuations in tinnitus symptoms, such as tinnitus loudness.
• CW999

  Caution! – Do not use the device if: You are pregnant, unless directed by a doctor.
• CW999

  Caution! – Do not use the device if: You are suffering from any intermittent or chronic neuralgia in the head and neck area.

Marché principal en Irlande ; disponible dans 5 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

05391540580042

Basic UDI-DI

539154058SM-301-EU2XG

Numéro de référence/catalogue

EU2

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

Lenire Tinnitus Treatment Device

URL des informations complémentaires

https://www.lenire.com/product-support/european-user-manuals-and-guides/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Z12149099VARIOUS ENT INSTRUMENTS - OTHER

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel