Organization name

Zucchetti Centro Sistemi SpA

SRN

IT-MF-000019013

Manufacturer status

Active

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

• Ask your pharmacist or doctor for advice before using or taking the product (e.g. if pregnant or breastfeeding)
• Consult healthcare professional before use
• Consult instructions for use
• To protect against accidental or unauthorised access to your personal and clinical data, do not share the password required to configure the Application with third parties. If you have any doubts about the dose to be administered, the configuration of the application, or how to use it, consult your diabetes specialist.

  OTHER

• The algorithm used to generate the suggested IAR dose is based on the customisations made during the configuration phase in the \"User settings\" section, and on the values set on the home page when entering the values for the bolus calculation. This information is intended to be collected and entered in the Application, under the sole and full responsibility of the user. Therefore, you should discuss the use of the calculator with your doctor and configure the settings as instructed by him/her.

  OTHER

• The use of the application requires training in a diabetes centre on the management of insulin therapy and carbohydrate counting, basic knowledge of smartphone tools as well as experience in using them.

  OTHER

• The application uses the colour red to indicate alert and warning situations, green to indicate normal situations, and yellow to indicate approaching critical situations. In the case of colour blindness or other disorders that lead to an alteration in colour perception, warnings indicated in red are also accompanied by alert messages that call for special attention. Caution is therefore required when such messages are displayed. In the event of a poorly lit or excessively bright environment, which could impair the visibility of the smartphone screen, please pay particular attention to the correct setting of the parameters.

  OTHER

• The use of the application by patients who do not have basic knowledge and autonomy in using smartphone tools or who have intellectual disabilities, could compromise correct use of the application.

  OTHER

• Failure to supervise or manage the application by a guardian for patients aged between 12 and 18 years or for patients with intellectual disabilities may compromise the proper use of the application.

  OTHER

Primary placement in Italy; available across 14 countries total.

Trade name

GlucoLog RapidCalc

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

08033866939698

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

803386693GL-RAPIDCALCHB

Reference / catalog number

GL-RAPIDCALC-A

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

GlucoLog RapidCalc is a mobile insulin bolus calculator app for diabetics with a bolus-basal regime, which can be used with Android and iOS smartphones. The insulin bolus is determined by an advanced calculation system, thanks to intelligent monitoring of active insulin and the selection of the insulin-carbohydrate ratio and glycaemic targets. The application is not intended to replace care provided by an authorised healthcare professional, including prescription, diagnosis, and treatment.

Additional information URL

https://sites.google.com/view/glucolog-rapidcalc-manual

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12040292GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE

• Class IIb medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.