Organization name

SD Biosensor Inc.

SRN

KR-MF-000009168

Manufacturer status

Active

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

• CW009

  EUDAMED did not publish a description for this code.

Primary placement in Italy; available across 23 countries total.

Trade name

STANDARD™ M10 Stool Pretreatment kit

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.

08800111718557

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.

88001117IPAA01MA13W9

Reference / catalog number

11PRT20A

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

10

Additional product description

STANDARD™ M10 Stool Pretreatment Kit is used to pretreat the unformed stool before processing for downstream nucleic acid extraction and molecular diagnostic testing.

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.

• W0105900201BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC

• IVDR Class A medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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