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SP5-1U Sensor Holder Package 115-042849-00

by Shenzhen Mindray Bio-Medical Electronics 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 Number06944904090030 UDI-DI Date23 Sep 2016ListedStatusListed 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  • Withdrawn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

Trade Name
SP5-1U Sensor Holder Package
Generic Name
General-purpose ultrasound imaging system
Model / Reference
115-042849-00
Primary DI / UDI-DI
06944904090030
510(k) Number
FDA Product Code
IYN
GMDN Term
General-purpose ultrasound imaging system
Device Class
Class II
Regulation Number
892.1550
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Category: General-purpose ultrasound imaging system

Cleared under the same submission (K162267)

Show all (12)

Other devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

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Properties

  • Prescription Use

Other properties (13)

  • 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No