Easyear

Dénomination commerciale

Easyear

05905718013326

B-05905718013326

Numéro de référence/catalogue

N/A

GS1

Classe III

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Easyear Ohrentropfen ist ein Medizinprodukt, das auf den osmotischen Eigenschaften von Glycerin basiert. Der wichtigste Inhaltsstoff von Easyear ist Glycerin. Glycerin hat zwei grundlegende Eigenschaften, die für seine Verwendung als Ohrentropfen wichtig sind: 1) die ölige Konsistenz von Glycerin, durch die es an der Applikationsstelle sanft an der Haut haftet und die für seine schützenden Eigenschaften verantwortlich ist, und 2) die Hygroskopizität von Glycerin, die dazu führt, dass topisch verabreichtes Glycerin geschwollenem Gewebe Wasser entzieht (osmotischer Effekt), was zu einer Verringerung der Schwellung und damit zur Linderung von Schmerzen führt.

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.

• Ne pas utiliser si l’emballage est endommagé

  Do not use: if the packaging has been damaged;

• • 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.

  AUTRE

• EUH 208 - Contient <nom de la substance sensibilisante>. Peut produire une réaction allergique.

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