Organization name

SD Biosensor Inc.

SRN

KR-MF-000009168

Manufacturer status

Active

Primary placement in Italy; available across 23 countries total.

Trade name

STANDARD™ i Cleanser

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.

08800111722660

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.

88001117IPAA04IA01W7

Reference / catalog number

16CL10

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

2

Additional product description

The STANDARD™ i Pre-Trigger, STANDARD™ i Trigger, STANDARD™ i Wash Buffer, STANDARD™ i Cleanser, and STANDARD™ i Assay Cup are in vitro diagnostic device accessories intended for use with the STANDARD™ i Chemiluminescence Immunoassay (CLIA) Analyzer. They enable and support the automated performance of chemiluminescent immunoassays, including reaction initiation, signal detection, washing, maintenance, and sample analysis.

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.

• W0201020185AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES

• IVDR Class A medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.