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Sensor kit for SOMNOscreen (extra small) SEN801

by Somnomedics GmbH

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04250413407408 UDI-DI Date10 Oct 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Sensor kit for SOMNOscreen (extra small)
Generic Name
Polysomnograph
Model / Reference
SEN801
Primary DI / UDI-DI
04250413407408
510(k) Number
FDA Product Code
MNR
GMDN Term
Polysomnograph
Device Class
Class II
Regulation Number
868.2375
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K201054)

Other devices from Somnomedics GmbH

See all devices from Somnomedics GmbH →

Properties

  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No