Skip to content

CORELab 1.0

by medimaps group SA

CORELab 1.0 is a Class I device made by medimaps group SA, listed in FDA GUDID since 29 Jun 2026 (UDI-DI B214CORELABV100), 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 NumberB214CORELABV100 UDI-DI Date29 Jun 2026ListedStatusListed 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  • Withdrawn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
CORELab
Generic name
Basic x-ray clinical assessment support software
Model / reference
1.0
Primary DI / UDI-DI
B214CORELABV100
FDA product code
LMD
GMDN term
Basic x-ray clinical assessment support software
Device class
Class I
Regulation number
892.2020
GUDID distribution status
In Commercial Distribution

Other devices from medimaps group SA

See all devices from medimaps group SA →

Properties

  • Premarket exempt
  • Lot / batch number
Other properties (13, all answered No)