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FungalBlue TFX-CTS

by Toefx, Inc.

FungalBlue TFX-CTS is a Class I device made by Toefx, Inc., listed in FDA GUDID since 3 Dec 2025 (UDI-DI 00860012465019), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860012465019 UDI-DI Date3 Dec 2025ListedStatusListed 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  • Withdrawn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
FungalBlue
Generic name
Skin marking pen, single-use
Model / reference
TFX-CTS
Primary DI / UDI-DI
00860012465019
FDA product code
FZZ
GMDN term
Skin marking pen, single-use
Device class
Class I
Regulation number
878.4660
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code FZZ (Marker, Skin).

Other devices from Toefx, Inc.

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)