FT.CE.109.9

Nom de l'organisation

GRUPPO FARMAIMPRESA SRL

SRN

IT-MF-000012625

Statut du fabricant

Actif

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

• CW999

  Keep out of reach of children.Single-dose applicators: the content of each tube should be used in a single administration.Store the product properly sealed and protected from light and heat sources.Do not use the product after the expiry date reported on the packaging.The expiry date is valid for the product properly stored.Do not use the product if the package is damaged or opened.The device is not sterile.It’s not a contraceptive.Semina Aquagel has no spermicidal activity.Do not use in case of damaged mucous membranes, post-surgery or acute vaginal infection.Do not swallow.Avoid contact with eyes.Do not use in case of individual ascertained hypersensitivity to the components present into the product.Do not use the product in conjunction with quaternary ammonia compounds.The incorrect observance of the warnings, of the methods of use, as well as the re-use of the same single-dose applicator, could compromise the efficacy of the product or cause the aggravation of existing problems or cause the onset of problems that were not previously present.For lactating women, the use of the gel should be limited to cases of real need and under the direct supervision of the doctor.Do not use the product for a period exceeding 30 consecutive days.It is important to inform your doctor or pharmacist of any side effects not described in this leaflet.

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

Dénomination commerciale

non renseigné

Code d'UDI-DI

D-FT.CE.109.9CN

Basic UDI-DI

B-FT.CE.109.9CN

Numéro de référence/catalogue

FT.CE.109.9

Entité d'attribution

EUDAMED

Catégorie de risque

Classe IIa

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Semina AQUAGEL Semina Aquagel is a vaginal lubricant that can be used in cases where conception is desired. Its formulation has been studied to:Create an optimal environment for spermatozoa.Contribute to maintain a pH value suitable for natural conception.Obtain an osmolarity compatible with the seminal fluid.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel

D-FT.CE.109.9CN

La génération de DataMatrix prend en charge les IUD émis par GS1. La prise en charge HIBCC / ICCBBA arrive bientôt.

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

• U0803VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS

Santé des certificats sur le portefeuille de ce fabricant.