SMARTBOLUS-01

Nom de l'organisation

Social Diabetes S.L.

SRN

ES-MF-000019618

Statut du fabricant

Actif

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

• CW030

  Check with a healthcare professional in addition to using the app and before making medical decisions
• CW010

  Check the manual for information about the implications of misunderstanding instructions in all official languages in Europe not covered by product translation
• CW999

  ● It is important to use this device under optimal conditions that avoid disturbance, lack of concentration and lack of awareness of the clinical impact of its use ● The device operation requires HCP with experience in the endocrinology area (diabetes, nutrition, metabolic syndrome) for monitoring and treatment of their patients with diabetes ● Improper use of the application, entering incorrect or nonactual data may cause adverse health risks to the patient ● The patient is responsible for the information entered, as well as for the use of the resulting data. ● Standard browsers are needed for user manual visualization. ● Be sure you are using the last version available of the device

Marché principal en Espagne ; disponible dans 32 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

84370243300024

Basic UDI-DI

B-84370243300024

Numéro de référence/catalogue

SMARTBOLUS-01

Entité d'attribution

GS1

Catégorie de risque

Classe IIb

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Software application intended to support insulin bolus calculation based on user-entered therapy parameters and treatment-related data. Legacy device under Directive 93/42/EEC.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Z12040192GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE

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