ABP501

Organization name

SOMNOmedics AG

SRN

DE-MF-000006921

Manufacturer status

Active

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

• CW999

  In the case of painful sensation or skin irritation, the measurement should be stopped immediately and the affected site checked. The pressure applied to the arm by the cuff and its sensors may cause slight and reversible pressure marks on the skin. The measurement should only be continued if the skin is intact and there is no further painful sensation after adjusting the position of the cuff.
• 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

04250413402960

Basic UDI-DI

42504134CUFF-ABPML6

Reference / catalog number

ABP501

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

—

Additional information URL

https://support.somnomedics.de/

Clinical sizes

No clinical sizes registered for this device.

• Z12100380ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES

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