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Hello Heart HHBPA-CUFFXL

by Health & Life Co., Ltd.

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

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 Number04719872489238 UDI-DI Date4 Dec 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Hello Heart
Generic Name
Automatic-inflation electronic sphygmomanometer, non-portable
Model / Reference
HHBPA-CUFFXL
Primary DI / UDI-DI
04719872489238
FDA Product Code
DXN
GMDN Term
Automatic-inflation electronic sphygmomanometer, non-portable
Device Class
Class II
Regulation Number
870.1130
GUDID distribution status
In Commercial Distribution

Other devices from Health & Life Co., Ltd.

See all devices from Health & Life Co., Ltd. →

Properties

  • Over-the-Counter
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No