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Tor 3 Black 8922

by Leloi AB

Tor 3 Black 8922 is a Class II device made by Leloi AB, listed in FDA GUDID since 26 Jun 2023 (UDI-DI 07350075028922), 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 Number07350075028922 UDI-DI Date26 Jun 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  • Withdrawn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
Tor 3 Black
Generic name
Penile ring
Model / reference
8922
Primary DI / UDI-DI
07350075028922
FDA product code
LKY
GMDN term
Penile ring
Device class
Class II
Regulation number
876.5020
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code LKY (Device, External Penile Rigidity).

Other devices from Leloi AB

See all devices from Leloi AB →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)