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ergoselect 1 195001

by ergoline GmbH

ergoselect 1 195001 is a Class II device made by ergoline GmbH, listed in FDA GUDID since 10 May 2023 (UDI-DI 04059358001821), 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 Number04059358001821 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  • Withdrawn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
ergoselect 1
Generic name
Bicycle ergometer
Model / reference
195001
Primary DI / UDI-DI
04059358001821
FDA product code
ISD
GMDN term
Bicycle ergometer
Device class
Class II
Regulation number
890.5360
GUDID distribution status
In Commercial Distribution
Size
Height — 1280 Millimeter
Length — 1000 Millimeter
Width — 440 Millimeter
Weight — 55 Kilogram

Similar devices

Other devices filed under FDA product code ISD (Exerciser, Measuring).

Other devices from ergoline GmbH

See all devices from ergoline GmbH →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)