Organization name

SOMNOmedics AG

SRN

DE-MF-000006921

Manufacturer status

Active

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

• 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

EEG sensor

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.

04250413405626

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.

42504134EEG-S6L

Reference / catalog number

SEW140

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

—

Additional information URL

https://support.somnomedics.de/

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.

• Z12100380ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES

• Class IIa medical devices in EUDAMED

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