38023

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

  Contraindication The Product must not be used in the case of hypersensitivity to medEctoin® or any of the other ingredients of the device. The Product must not be used for patients below 3,5 kg bodyweight. Warnings and Precautions If allergic reactions occur, the use of the Product must be discontinued immediately. Do not use the device if it is damaged or punctured. To ensure safe hygiene, each nasal spray bottle is to be used by one person only. Do not use for more than 3 months after opening. Do not use after expiry date. Keep out of reach of children. If conditions persist or worsen, contact your healthcare provider. If you have applied a higher amount of the Product than you should, no negative effects are expected. If you are experiencing discomfort, please contact a doctor. Additional information If the Product is used within its intended use, there is no evidence for a particular risk during pregnancy and breast-feeding. Should any serious incident be related to the Product, please report it to the legal manufacturer at vigilance@bitop.de and the responsible local competent authority.

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

Dénomination commerciale

non renseigné

Code d'UDI-DI

04260265220117

Basic UDI-DI

426026522SNS013K9Y

Numéro de référence/catalogue

38023

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

—

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Q0399ENT DEVICES - OTHER

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