Organization name

SD Biosensor Inc.

SRN

KR-MF-000009168

Manufacturer status

Active

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

• CW999

  - The STANDARD™ LMS is for managing your results only. If you are a home user, do not change treatments of your disease without your healthcare professional’s order. The STANDARD™ LMS should not be used for therapeutic and diagnostic purpose. - Do not measure lipid or glucose using the blood while the device is connected to a PC. If you do a test with the communication, there may be the risk of electrical shock. - 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 32 countries total.

Trade name

STANDARD™ LMS (Lipid Management Software)

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.

08800111724831

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.

88001117IAAA01PA14L7

Reference / catalog number

02LMS10

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

STANDARD™ LMS (Lipid Management Software) is PC based software for use in the home and professional settings to help people with cholesterol/triglycerides-related diseases and diabetes, and their healthcare professionals in storing and displaying test results from the STANDARD™ LipidoCare Analyzer for an effective cholesterol/triglycerides and diabetes management. It is intended for use as an accessory of STANDARD™ LipidoCare Analyzer.

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

Certificate health across this manufacturer's portfolio.

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