n/a

Trade name

not provided

UDI-DI code

05902020885993

Basic UDI-DI

B-05902020885993

Reference / catalog number

n/a

Issuing entity

GS1

Risk category

Class III

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Auridol es un producto sanitario cuyo mecanismo de acción se basa en las propiedades osmóticas del glicerol. El componente principal de las gotas óticas Auridol es el glicerol. El glicerol presenta dos características fundamentales desde el punto de vista de su uso en gotas para el oído: su consistencia oleosa, que permite una suave adhesión a la piel en el lugar de aplicación y contribuye a sus propiedades protectoras, y su carácter higroscópico, gracias al cual el glicerol aplicado localmente extrae agua de los tejidos inflamados (efecto osmótico), lo que reduce la hinchazón y, en consecuencia, la intensidad del dolor.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• M9002PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)

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

• CW007

  If the packaging has been damaged.
• CW999

  if the ear drum is damaged (e.g. chronic otitis media); • medical device should only be used after a thorough otoscopic examination by a doctor; • the expiry date printed on the packaging has expired; • the patient is immediately after surgery or surgical treatment in the ear; • in children under 6 months of age; • in case of prolonged pain or swelling caused by inflammatory condition with bacterial or fungal basis, these ailments require contact with a doctor; • in case of ear discharge - leakage from the ear; • medical device should not be applied to the ear with the hearing aid fitted, medical device should be applied one hour before the hearing aid is ingested into the outer ear canal; • although there is no evidence that medical device drops have a negative effect when used during pregnancy and breast-feeding, the use of medical device drops should be consulted with a doctor who should assess whether the expected benefits of it exceed the potential risk; • if symptoms intensify or there is no improvement after three days of using medical device ear drops or if you have a fever, contact your doctor. Prolonged pain or swelling may signal a bacterial or fungal infection that may require further and more appropriate treatment; • for external use only; • avoid contact with eyes, mouth and throat and nose mucous membranes; • It is intended for temporary relief of ear pain, no longer than 3 days and should not be used chronically.
• CW129

  An allergy to any of the components of the product has been previously detected; (glycerol and lidocaine).

No certificate specifically references this device's Basic UDI-DI.