FEMINA COMFORT

Dénomination commerciale

FEMINA COMFORT

Code d'IUD-ID

ID primaire

L'ID primaire est l'IUD-ID principal qu'un fabricant désigne comme identifiant de référence d'un dispositif dans EUDAMED.

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05904335216936

IUD-ID de base

IUD-ID de base

L'IUD-ID de base est l'identifiant principal qui regroupe toutes les variantes d'un même modèle de dispositif — la clé de la « famille » réglementaire.

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B-05904335216936

Numéro de référence/catalogue

FEMINA COMFORT Vaginal gel 7 disposable applicators with gel and instructions for use. English language version

Entité d'attribution

Entités d'attribution IUD

Les entités d'attribution sont les organismes que la Commission européenne a désignés pour attribuer les identifiants uniques des dispositifs au titre du système IUD de l'UE.

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GS1

Catégorie de risque

Classes de risque RDM

Les classes de risque du RDM classent les dispositifs médicaux du risque le plus faible (classe I) au plus élevé (classe III), ce qui détermine le niveau de contrôle réglementaire.

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Classe IIa

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Gel which creates a protective layer on the mucous membranes that moisturises them and protects them against damage to the epithelial surface resulting from vaginal dryness during sexual intercourse, gynaecological examination or physical activity. Using this medical product improves vaginal elasticity and maintains and restores the vagina’s physiological pH, which helps maintain the correct microbial flora in the vagina and reduces unpleasant smells. Intended for women in their reproductive years and during menopause, in order to alleviate the symptoms of vaginal dryness (discomfort, tension, itching, burning of vaginal mucous membranes) related to: -atrophy of vaginal mucous membranes; -deficiency of oestrogen; -long term stress. In order to help moisturise the vaginal epithelial surface: - after surgical and gynaecological procedures; - after abrasions or other minor mechanical traumas of the vaginal mucous membranes; - after labour; - after chemotherapy, radiotherapy, cryotherapy; - after laser treatments; - at the occurrence of changes resulting from the use of hormonal drugs; - during the perimenopausal period. The gel alleviates abrasions and helps moisturise the vaginal mucous membranes which promotes discomfort reduction during sexual intercourse. The product is also recommended for protection from negative changes in the vagina’s microbial flora and pH (e.g. caused by travelling, swimming-pools, sauna, fitness, antibiotics) through moisturising and maintaining the vagina’s natural pH. The product reduces unpleasant vaginal smell.

URL des informations complémentaires

https://www.lideal.pl/

Dimensions cliniques

• 5 MU03

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

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

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

• CW999

  Do not use in case of hypersensitivity (allergy) to any of the product ingredients. If burning, itching or redness occur when using the product, stop using it immediately and, if symptoms persist, contact a doctor or pharmacist. Consult a doctor or pharmacist prior to use during pregnancy or breast-feeding. Do not use when attempting to conceive as the gel pH can negatively affect semen. Do not use when menstruating. If vaginal dryness symptoms persist, consult a doctor or pharmacist. If vaginal infection occurs, use the product only after consulting a doctor or pharmacist. Avoid accidental contact of the gel with the mucous membrane of the eye, nose or mouth. Do not use together with local anaesthetics or other vaginal products, including vaginal birth control products, as it may impair their effects. Due to the presence of lactic acid, minor skin reactions may occur (a slight burning or itching sensation), especially in case of excessive vaginal dryness. These symptoms are usually temporary and should disappear naturally. Do not use the product if the applicator is damaged. Do not reuse an open applicator. Do not use after the expiry date. The product is intended for vaginal use only. Do not swallow!

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