SEN007/25

Organization name

SOMNOmedics AG

SRN

DE-MF-000006921

Manufacturer status

Active

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

• CW999

  All materials in contact with the skin are biocompatible. In rare cases, minor and reversible skin reactions may occur due to individual sensitivity, skin type, prolonged use, or environmental factors such as pressure or moisture.
• CW010

  EUDAMED did not publish a description for this code.
• CW036

  EUDAMED did not publish a description for this code.
• CW135

  EUDAMED did not publish a description for this code.
• CW014

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 32 countries total.

Trade name

not provided

UDI-DI code

04250413403288

Basic UDI-DI

42504134HST-AgBE

Reference / catalog number

SEN007/25

Issuing entity

GS1

Risk category

Class I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://support.somnomedics.de/

Clinical sizes

No clinical sizes registered for this device.

• Z1203020285MULTI-PARAMETER MONITORS - CONSUMABLES

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