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Ultra EX Size 1.0

by Jiangxi Yiles Medical Co., Ltd

Ultra EX Size 1.0 (1038010) is a Class I device made by Jiangxi Yiles Medical Co., Ltd, listed in FDA GUDID since 10 Aug 2023 (UDI-DI 06970888443814), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06970888443814 UDI-DI Date10 Aug 2023ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Ultra EX
Generic name
Laryngeal mask airway, reusable
Model / Ref / Catalog
Size 1.0, 1038010
Primary DI / UDI-DI
06970888443814
FDA product code
CAE
GMDN term
Laryngeal mask airway, reusable
Device class
Class I
Regulation number
868.5110
GUDID distribution status
In Commercial Distribution

Related devices

Category: Laryngeal mask airway, reusable

Other devices from Jiangxi Yiles Medical Co., Ltd

See all devices from Jiangxi Yiles Medical Co., Ltd →

Properties

  • Supplied sterile
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)