Organization name

IGLUCO TECH, S.L.

SRN

ES-MF-000001959

Manufacturer status

Active

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

• Consult instructions for use
• • The use of this device is prohibited in insulin-dependent type I diabetic patients whose diabetes is not controlled. Please, if you are a type I diabetic, consult your doctor before starting to use the device. • In pregnant and breastfeeding women. • In pediatric patients.

  OTHER

• • Device requires user calibration with blood glucose values. You should update the GLUCUBE calibration every two weeks at a minimum to ensure device performance. The performance of the GLUCUBE when calibrated less frequently than the recommended minimum of every two weeks, has not been studied. • Treatment decisions and dose adjustments should not be based solely on the results from GLUCUBE. If GLUCUBE result is outside the ranges established by the health professional, you must use a blood glucose meter to contrast the measurement and to follow their instructions.

  OTHER

Primary placement in Spain; available across 20 countries total.

Trade name

GLUCUBE

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.

08445586000006

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.

8445586ES0201S4

Reference / catalog number

ES0201

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 IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

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.

• Z1204011501NON INVASIVE BLOOD SUGAR MONITORING SYSTEMS

• Class IIa medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.

This device is not currently linked to any other device.