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Ultroting XTS-AISW-D2

by Shenzhen Magnet Technology Co., Ltd

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 Number06979053570010 UDI-DI Date16 Jun 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  • Withdrawn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
Ultroting
Generic Name
Bone-conduction hearing aid, head-worn
Model / Reference
XTS-AISW-D2
Primary DI / UDI-DI
06979053570010
510(k) Number
FDA Product Code
LXB
GMDN Term
Bone-conduction hearing aid, head-worn
Device Class
Class II
Regulation Number
874.3302
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K261256)

Other devices from Shenzen Magnet Technology Co., Ltd

Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • 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
  • Expiration Date: No