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SOMNOtouch™ RESP eco TOR050-E-U

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 Number04250413404858 UDI-DI Date7 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  • Withdrawn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
SOMNOtouch™ RESP eco
Generic Name
Home-use sleep apnoea recording system
Model / Reference
TOR050-E-U
Primary DI / UDI-DI
04250413404858
510(k) Number
FDA Product Code
MNR
GMDN Term
Home-use sleep apnoea recording system
Device Class
Class II
Regulation Number
868.2375
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K140861)

Show all (9)

Other devices from Somnomedics GmbH

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Properties

  • Prescription Use
  • Serial Number

Other properties (12)

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