ECG-EXPERT

Organization name

CUSTOM SOFTWARE & ELECTRONICS, S.L

SRN

ES-MF-000003031

Manufacturer status

Active

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

• CW999

  ECG-Expert should not be used by patients with known skin reactions to the electrode material. In some people, it may cause redness in the area where the electrodes are placed. ECG-Expert should not be used on areas of the patient’s torso where there are open wounds, rashes, or lesions that come into direct contact with the skin.

Primary placement in Spain; available across 3 countries total.

Trade name

not provided

UDI-DI code

08437017782018

Basic UDI-DI

8437017782018ECGEXPERTDP

Reference / catalog number

ECG-EXPERT

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Medical device intended for use by a healthcare professional in a clinical setting to measure electrical potentials on the body’s surface, record the heart’s electrical activity, and display it graphically, in order to assist the physician in evaluating cardiac electrical physiology (electrocardiography, ECG). The duration of use is typically 5 to 10 minutes.

Additional information URL

https://www.medicalcse.com/

Clinical sizes

No clinical sizes registered for this device.

• Z12050301GENERAL PURPOSE ELECTROCARDIOGRAPHS

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

This device is not currently linked to any other device.