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SafeBeat Rx App v2.1830.2223.160

by SafeBeat Rx, Inc.

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 Number00850043189107 UDI-DI Date4 May 2026ListedStatusListed 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  • Withdrawn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
SafeBeat Rx App
Generic Name
Electrocardiographic long-term ambulatory recording analyser application software
Model / Reference
v2.1830.2223.160
Primary DI / UDI-DI
00850043189107
510(k) Number
FDA Product Code
DQK, DPS
GMDN Term
Electrocardiographic long-term ambulatory recording analyser application software
Device Class
Class II
Regulation Number
870.1425, 870.2340
GUDID distribution status
In Commercial Distribution

Other devices from SafeBeat Rx, Inc.

Properties

Other properties (14)

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