SD-BOLUS-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 ● Healthcare professionals (HCP) will be requested about their professional condition as an HCP. The device operation requires HCP with experience in the endocrinology area (diabetes, nutrition, metabolic syndrome) for monitoring and treatment of their patients with diabetes. ● The software should only be used in combination with equipment with the listed minimum system requirements (App and Medical Platform). ● 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

84370243300017

Basic UDI-DI

8437024330Z120302029200DV

Numéro de référence/catalogue

SD-BOLUS-01

Entité d'attribution

GS1

Catégorie de risque

Classe IIb

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

SOCIALDIABETES is a stand-alone medical device software intended for better glycemic control by: self-control of diabetes in patients by calculation and recommendation of insulin dosage; and monitorization and treatment of diabetes by healthcare professionals (HCP).

URL des informations complémentaires

https://www.socialdiabetes.com/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Z1203020292MULTI-PARAMETER MONITORS - MEDICAL DEVICE SOFTWARE

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