1-channel EEG option for SOMNOtouch RESP

FDA UDI

Class II (US FDA UDI)

by Somnomedics GmbH

Identity

Trade Name: 1-channel EEG option for SOMNOtouch RESP FDA UDI
Generic Name: Polygraph FDA UDI
Model / Reference: TOS041 FDA UDI

Identifiers

Primary DI / UDI-DI: 04250413404049 FDA UDI
510(k) Number: K140861 FDA UDI
FDA Product Code: MNR FDA UDI
GMDN Term: Polygraph FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.2375 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Polygraph

1-channel EEG option for SOMNOtouch RESP by Somnomedics GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polygraph.

SOMNOtouch RESP accessory — Somnomedics GmbH · Class II
SOMNOtouch RESP Add-on device — Somnomedics GmbH
SOMNOtouch RESP — Somnomedics GmbH · Class II
SOMNOscreen plus EEG32 Tele Set — Somnomedics GmbH
AASM Headbox — Somnomedics GmbH
Simplified Sleep Stage Evaluation for SOMNOtouch RESP — Somnomedics GmbH
SOMNOtouch RESP accessory — Somnomedics GmbH · Class II
SOMNOtouch RESP accessory — Somnomedics GmbH · Class II

Cleared under the same submission

K140861 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Somnomedics GmbH

Sources (1)

FDA UDI 4fab0ea2-983b-404f-abb7-e0a2e2617fbc 33 fields · synced Jun 8, 2026