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HealX 1

by Swift Medical, Inc.

HealX 1 is a Class I device made by Swift Medical, Inc., listed in FDA GUDID since 4 Oct 2019 (UDI-DI 00627987231120), 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 Number00627987231120 UDI-DI Date4 Oct 2019ListedStatusListed 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  • Withdrawn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
HealX
Generic name
Radiological image marker, noninvasive, single-use
Model / reference
1
Primary DI / UDI-DI
00627987231120
FDA product code
FTY
GMDN term
Radiological image marker, noninvasive, single-use
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiological image marker, noninvasive, single-use

Similar devices

Other devices filed under FDA product code FTY (Tape, Measuring, Rulers And Calipers).

Other devices from Swift Medical, Inc.

See all devices from Swift Medical, Inc. →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)