Skip to content

Na P54

by GuangDong Youkey 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 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06974757650112 UDI-DI Date9 Nov 2023ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Hand-held ultrasound imaging system, body-surface
Model / Reference
P54
Primary DI / UDI-DI
06974757650112
510(k) Number
FDA Product Code
ITX
GMDN Term
Hand-held ultrasound imaging system, body-surface
Device Class
Class II
Regulation Number
892.1570
GUDID distribution status
In Commercial Distribution

Related devices

Category: Hand-held ultrasound imaging system, body-surface

Cleared under the same submission (K211746)

Other devices from GuangDong Youkey Medical Co., Ltd.

  • Na P56

    Class II

  • Na P55

    Class II

  • Na P51

    Class II

  • Na P52

    Class II

  • Na P53

    Class II

  • Na P50

    Class II

See all devices from GuangDong Youkey Medical Co., Ltd. →

Properties

  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No