38070

Nom de l'organisation

bitop AG

SRN

DE-MF-000006543

Statut du fabricant

Actif

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

• CW999

  If allergic reactions occur, discontinue use immediately. Do not use damaged products. Before each application, the applicator must be carefully checked for its integrity. Do not use the applicator, if it is damaged (e.g. has visible cracks or chips) or its plunger is loosened and disassembles from the tube easily. To ensure safe hygiene, this product should only be used by one person. Do not use for more than 3 months after opening. Keep out of reach of children. If conditions persist or worsen, or if signs of infection (as a vaginal discharge of an unusual colour/consistency/odour) occur, contact your healthcare provider or pharmacist. The product is neither spermicide, nor supporting conception. The product does not protect against sexually transmitted diseases. The product has no contraceptive action and cannot be used to prevent pregnancy. Product should not be used in case of hypersensitivity to Ectoin®, Propylene Glycol or any of the other ingredients of the gel. Do not use in case of traumas or surgeries in the vaginal area. Do not use during vulvovaginal infections. Do not use the intravaginal applicator during pregnancy. Not all minor constituents of the product have been extensively investigated for safety during pregnancy and breast-feeding. In the absence of sufficient data, the use of the product during pregnancy and while breast-feeding is not recommended. Patients unable to use the product on their own should be assisted during the application the product. The product is intended for use in adults.

Marché principal en Pays-Bas ; disponible dans 1 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

D-DE-MF-000006543-38070UD

Basic UDI-DI

B-DE-MF-000006543-38070UD

Numéro de référence/catalogue

38070

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

—

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• U0899GYNAECOLOGICAL DEVICES - OTHER

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

Santé des certificats sur le portefeuille de ce fabricant.