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Onera STS 2 01.00

by Onera B.V. 10 variants

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 Number08720256698364 UDI-DI Date15 May 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  • Withdrawn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
Onera STS 2
Generic Name
Polysomnography analyser
Model / Ref / Catalog
01.00, ONERA STS 2 – ONERA SLEEP APP iOS US
Primary DI / UDI-DI
08720256698364
510(k) Number
FDA Product Code
MNR, OLV
GMDN Term
Polysomnography analyser
Device Class
Class II
Regulation Number
868.2375, 882.1400
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K243220)

Other devices from Onera B.V.

See all devices from Onera B.V. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • 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
  • Serial Number: No
  • Expiration Date: No