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Hisense L15-5EB

by Qingdao Hisense Medical 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 Number06978311952087 UDI-DI Date30 Sep 2025ListedStatusListed 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  • Withdrawn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
Hisense
Generic Name
Extracorporeal ultrasound imaging transducer, hand-held
Model / Reference
L15-5EB
Primary DI / UDI-DI
06978311952087
510(k) Number
FDA Product Code
IYN, IYO, ITX
GMDN Term
Extracorporeal ultrasound imaging transducer, hand-held
Device Class
Class II
Regulation Number
892.1550, 892.1560, 892.1570
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K233439)

Show all (12)

Other devices from Qingdao Hisense Medical Co., Ltd.

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Properties

  • Prescription Use
  • Serial 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
  • Lot / Batch Number: No
  • Expiration Date: No