Organization name

SD Biosensor Inc.

SRN

KR-MF-000009168

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW011

  - Please read instructions carefully before you perform the test. - Inform your SD Biosensor representative and your local competent authority about any serious incidents which may occur when using this product.

Primary placement in Romania; available across 30 countries total.

Trade name

GlucoNavii® App

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.

08800111724800

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.

88001117IAAA01PA16LB

Reference / catalog number

01APP10

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

IVDR risk classes

IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.

IVDR Class A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

GlucoNavii® App is smartphone application for use in the home and professional settings to help people with diabetes and their healthcare professionals in storing and displaying of glucose test results from the blood glucose meter for an effective diabetes management. It is intended for use as an accessory to the compatible SD Biosensor brand blood glucose meter. The available blood glucose meters are followings: - STANDARD™ Mentor BT - STANDARD™ GlucoNavii® NFC - STANDARD™ GlucoNavii® PRO BT

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.

• W0201010182CHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES

• IVDR Class A medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.