SkinScanner-M v1.0

Organization name

Dermus Kft

SRN

HU-MF-000022335

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW011

  Do not use the device to examine bleeding or purulent skin surfaces. Do not touch the device to such surfaces. Do not use the device to examine the skin of the eyelid. Keep the number of examinations on a specific skin area of a specific patient as low as reasonably achievable.
• CW036

  The device should not be used on the patient while the neutral electrode of a high frequency (HF) surgical equipment is connected to the patient.

Primary placement in Hungary; available across 32 countries total.

Trade name

SkinScanner-M v1.0

UDI-DI code

05999862285005

Basic UDI-DI

5999862285SSM00144

Reference / catalog number

1

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

The device is designed for ultrasound skin imaging, by extending this with capturing optical top-view images at the same location. The exact location of the cross-sectional depth image is marked on the optical image. This feature aids the precise localization of the ultrasound image with respect to the surface of the skin, helping the user choose the desired location of ultrasound recording.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z11040103PORTABLE ULTRASOUND SCANNERS

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

This device is not currently linked to any other device.