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icompanion 1

by icometrix NV

icompanion 1 is a self-care monitoring/reporting software (FDA Class I; FDA product code NXQ, Reminder, Medication) made by icometrix NV, listed in FDA GUDID since 22 Sep 2023 (UDI-DI B621ICOMPANION103), 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 NumberB621ICOMPANION103 UDI-DI Date22 Sep 2023ListedStatusListed 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  • Withdrawn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
icompanion
Generic name
Self-care monitoring/reporting software
Model / reference
1
Primary DI / UDI-DI
B621ICOMPANION103
FDA product code
NXQ
GMDN term
Self-care monitoring/reporting software
Device class
Class I
Regulation number
890.5050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Self-care monitoring/reporting software

Similar devices in this category

Other devices filed under Self-care monitoring/reporting software.

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Properties

  • Premarket exempt
Other properties (14, all answered No)