SD-BOLUS-01

Organization name

Social Diabetes S.L.

SRN

ES-MF-000019618

Manufacturer status

Active

3 warnings recorded — scroll inside the panel to see all entries.

• 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

Primary placement in Spain; available across 32 countries total.

Trade name

not provided

UDI-DI code

84370243300017

Basic UDI-DI

8437024330Z120302029200DV

Reference / catalog number

SD-BOLUS-01

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

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).

Additional information URL

https://www.socialdiabetes.com/

Clinical sizes

No clinical sizes registered for this device.

• Z1203020292MULTI-PARAMETER MONITORS - MEDICAL DEVICE SOFTWARE

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