Organization name

SD Biosensor Inc.

SRN

KR-MF-000009168

Manufacturer status

Active

Primary placement in Italy; available across 22 countries total.

Trade name

STANDARD™ d-BLOCK Incubator

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.

08800111702273

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.

88001117IPAA01AA03TJ

Reference / catalog number

12INC10

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™ d-Block Incubator is an in vitro diagnostic device intended specifically to be used together with SDB products. STANDARD™ d-Block Incubator provides an environment set to the suitable temperature to the SDB strip devices and tubes before in-vitro-diagnostic examinations. This product can be set from 35°C (95°F) to 40°C (104°F) and its temperature range is a good environment for optimizing the reaction of the SDB products used together. The product is intended to be used by trained healthcare or laboratory professionals or other health care workers who have received appropriate training.

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.

• W02069099VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER

• IVDR Class A medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.