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Onera STS 01.00

by Onera B.V. 7 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 Number08720256698463 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  • Withdrawn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
Generic Name
Polysomnography analyser
Model / Ref / Catalog
01.00, ONERA STS1 CHEST US
Primary DI / UDI-DI
08720256698463
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
MRI Safety
MR Unsafe
Size
Weight — 20 Gram
Height — 15 Millimeter
Width — 70 Millimeter
Length — 28 Millimeter

Related devices

Cleared under the same submission (K210593)

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Cleared under the same submission (K223573)

Other devices from Onera B.V.

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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