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ers2 Basic Software 161801

by ergoline GmbH

ers2 Basic Software 161801 is a Class II device made by ergoline GmbH, listed in FDA GUDID since 10 May 2023 (UDI-DI 04059358001838), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04059358001838 UDI-DI Date10 May 2023ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
ers2 Basic Software
Generic name
Cardiopulmonary parameter spot-check measurement software
Model / reference
161801
Primary DI / UDI-DI
04059358001838
FDA product code
DRG
GMDN term
Cardiopulmonary parameter spot-check measurement software
Device class
Class II
Regulation number
870.2910
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency).

Other devices from ergoline GmbH

See all devices from ergoline GmbH →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)