CEP001C

Nom de l'organisation

NEXTEC medical GmbH

SRN

DE-MF-000005572

Statut du fabricant

Actif

2 avertissements enregistrés — faire défiler le panneau pour tout voir.

• CW999

  CERAPRO MED Skin Barrier Cream should not be used if you are hypersensitive to any of the ingredients.
• CW999

  Do not apply to mucous membranes such as your eyes, on your eyelids, inside your mouth/nose, auditory canal, vagina or penis, anus and deep wounds.

Marché principal en Belgique ; disponible dans 5 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

04260705080103

Basic UDI-DI

426070508MD-SKINCERA22XB

Numéro de référence/catalogue

CEP001C

Entité d'attribution

GS1

Catégorie de risque

Classe IIa

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

CERAPRO MED Skin Barrier Cream is a substance based medical device intended to form a film-like barrier on the skin preventing loss of moisture. Additionally, it lowers the skin pH and maintains it for at least 12 hours as shown clinically. This is thought to support the skin´s inherent antimicrobial defence system. Particularly patients suffering from atopic dermatitis are likely to benefit from these effects. Atopic dermatitis is characterized by (1) dysfunction of the skin barrier leading to increased loss of water in the upper layer of the skin and hence dry skin, and (2) inflammation and elevated skin pH linked to increased colonization with pathogenic microorganisms. The skin barrier is formed by the outermost layer of the skin (stratum corneum) consisting of keratinenriched cells embedded in lipid lamellae which determine the selective permeability of the skin and are primarily composed of ceramides, cholesterol, and free fatty acids such as linoleic acid. Accordingly, impairment of skin barrier function associated with atopic dermatitis is typically linked to changes in the lipid composition of the stratum corneum.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

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

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