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Commwell ECG Sentinel System

by Commwell Research & Development 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 Number07290012672071 UDI-DI Date24 Aug 2026ListedStatusListed 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  • Withdrawn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
Commwell
Generic Name
Telemetric electrocardiographic ambulatory recorder
Model / Ref / Catalog
ECG Sentinel System, 5-062-00
Primary DI / UDI-DI
07290012672071
510(k) Number
FDA Product Code
DXH
GMDN Term
Telemetric electrocardiographic ambulatory recorder
Device Class
Class II
Regulation Number
870.2920
GUDID distribution status
In Commercial Distribution

Other devices from Commwell Research & Development Ltd.

Properties

  • Serial Number
  • Manufacturing Date

Other properties (12)

  • 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
  • Expiration Date: No