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Leona Basic Large

by Loon Lab Inc.

Leona Basic Large is a Class II device made by Loon Lab Inc., listed in FDA GUDID since 20 Jun 2019 (UDI-DI 08809599750066), 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 Number08809599750066 UDI-DI Date20 Jun 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  • Withdrawn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
Leona
Generic name
Menstrual cup/disc, non-latex, reusable
Model / reference
LEONA BASIC LARGE
Primary DI / UDI-DI
08809599750066
FDA product code
HHE
GMDN term
Menstrual cup/disc, non-latex, reusable
Device class
Class II
Regulation number
884.5400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Menstrual cup/disc, non-latex, reusable

Similar devices

Other devices filed under FDA product code HHE (Cup, Menstrual).

Other devices from Loon Lab Inc.

See all devices from Loon Lab Inc. →

Properties

  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)