LUCOOLIFE Purple -T/S/L

by Ningbo Luke Medical Devices Co., Ltd.

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number06970240895480 UDI-DI	Date27 Jul 2023Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Lucoolife
Generic Name: Menstrual cup/disc, non-latex, reusable
Model / Reference: Purple -T/S/L

Primary DI / UDI-DI: 06970240895480
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

Sterilization Method: Moist Heat or Steam Sterilization

Other devices from Ningbo Luke Medical Devices Co., Ltd.

LUCOOLIFE Pink-T/S/L

Class II
LUCOOLIFE lucency-T/S/L

Class II

Properties

Premarket Exempt
Lot / Batch Number

Other properties (12)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Prescription Use: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No