n/a

Dénomination commerciale

non renseigné

Code d'IUD-ID

05902020885993

IUD-ID de base

B-05902020885993

Numéro de référence/catalogue

n/a

Entité d'attribution

GS1

Catégorie de risque

Classe III

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

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.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

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

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

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

• 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).

Aucun certificat ne référence l'IUD-ID de base de ce dispositif.