Organization name

DIRUI INDUSTRIAL CO., LTD

SRN

CN-MF-000001891

Manufacturer status

Active

Primary placement in Austria; available across 32 countries total.

Trade name

Urine Sediment Analyzer Reagent Sheath

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.

06925794577306

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.

69257945W010106020302R0FD

Reference / catalog number

3019967

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

As automated reagent and auxiliary reagent, it is used to wrap the urine sample to form a sheath flow. The reagent itself has no diagnostic function. 1×20L

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.

• W010106020302URINE SEDIMENT TEST KIT (AUTOMATED)

• IVDR Class A medical devices in EUDAMED

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