Organization name

Samsung Electronics Co.,Ltd

SRN

KR-MF-000020682

Manufacturer status

Active

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

• CW018

  This device is not intended for mammographic applications, fluoroscopy and moving grid features.

Primary placement in Poland; available across 13 countries total.

Trade name

GR40CW

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.

08806088773797

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.

8806090DGRGR001YN

Reference / catalog number

GR40CW

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

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

GR40CW, the retrofit kit for digital radiography, is equipment that acquires images by detecting X-rays that have passed through a patient’s body. The X-ray passing through a patient’s body is sent to the detector and then it is converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process device before being sent to the S-STATION (Operation Software) and saved in DICOM file, a standard for medical imaging. The captured images are sent to the Picture Archiving & Communication System (PACS) server, and can be used for reading images.

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.

• Z11031180SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES

• Class IIa medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.