EU3

Organization name

Neuromod Devices Limited

SRN

IE-MF-000004261

Manufacturer status

Active

11 warnings recorded — scroll inside the panel to see all entries.

• 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

  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 are suffering from any intermittent or chronic neuralgia in the head and neck area.
• CW999

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

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

  Headaches may accompany use of the treatment device.
• 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 are pregnant, unless directed by a doctor.
• CW999

  Caution! – Do not use the device if: You suffer from epilepsy or any other condition that may result in loss of consciousness.

Primary placement in Ireland; available across 5 countries total.

Trade name

not provided

UDI-DI code

05391540580059

Basic UDI-DI

539154058SM-301-EU3XJ

Reference / catalog number

EU3

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Lenire Tinnitus Treatment Device

Additional information URL

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

Clinical sizes

No clinical sizes registered for this device.

• Z12149099VARIOUS ENT INSTRUMENTS - OTHER

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification