Organization name

SD Biosensor Inc.

SRN

KR-MF-000009168

Manufacturer status

Active

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

• CW010

  Consult instructions for use
• CW011

  EUDAMED did not publish a description for this code.
• CW273

  To avoid the risk of electric shock, the devices must only be connected to a supply mains with protective earth.

Primary placement in Italy; available across 21 countries total.

Trade name

STANDARD™ M10 Console

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.

08800111710032

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.

88001117IPAA01MA01W2

Reference / catalog number

M10-01C/11M1011

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

The STANDARD M10 is an in vitro diagnostic device that measures quantitative or qualitative biomarkers of human specimens such as blood, urine, and nasal mucus in a laboratory or POCT environment. STANDARD M10 consists of STANDARD M10 Console and STANDARD M10 Module (Cartridge analysis function). The STANDARD M10 Console is a device that operates the STANDARD M10 Module based on the information obtained by scanning the 2D barcode of the cartridge. The M10 Console displays the results of monitoring and diagnosis of the inserted specimen. It must be used with designated test cartridges produced by SD Biosensor Co., Inc. For details on specific tests, refer to the instructions included in each of test cartridge packages.

Additional information URL

http://www.sdbiosensor.com/

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.

• W02050116NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS

• IVDR Class A medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.