ENT37

Nom de l'organisation

Gofarm Sp. z o.o. Sp. k.

SRN

PL-MF-000003485

Statut du fabricant

Actif

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• CW999

  If there is no improvement within 14 days or if symptoms worsen, stop using the product and consult a doctor. If you are pregnant or breast-feeding, suspect you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this product. For hygiene reasons and to avoid the transmission of infection, it is recommended to use one product by one person. Do not use the product after the expiration date stated on the packaging or if the packaging is damaged. Hypersensitivity (allergy) to any ingredient of the product. Do not use in the eyes or inside the ear. Do not use in the case of large mouth ulcers (painful ulceration 10-20 mm in size). Do not use in the case of severe clinical form of recurrent aphthosis (painful erosions or ulcers, partially healing, partially appearing de novo in another place, with a size of 5 to 10 mm).

Marché principal en Portugal ; disponible dans 1 pays au total.

Commercialisé en Portugal ; dates par pays non publiées.

Dénomination commerciale

non renseigné

Code d'UDI-DI

D-5600954026818XR

Basic UDI-DI

B-5600954026818XR

Numéro de référence/catalogue

ENT37

Entité d'attribution

EUDAMED

Catégorie de risque

Classe I

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Prodentix Wells Gel para Aftas is a medical device in the form of a coating gel used to create a protective film on the surface of the oral mucosa, which isolates the area with erosion or ulceration caused by irritants. It alleviates symptoms, including burning and soreness caused by mouth ulcers, and supports the proper renewal of the epithelium in the oral cavity.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

• 15 MU03

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

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

Santé des certificats sur le portefeuille de ce fabricant.