Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009881291

FEI Number

3009881291

Entity Name

SHENZhEN KEAN SILICONE PRODUCT CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

#52 Xinhe Road, Baolai Industrial Zone, Shangmugu, Pinghu Longgang District, Shenzhen Guangdong 518111, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Shenzhen Kean Silicone Product Co., Ltd. (Owner Number: 10051439)

Owner / Operator Contact Address

#52 Xinhe Road, Baolai Industrial Zone, Shangmugu, Pinghu Longgang District, Shenzhen, CN-GD 518111, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cup, menstrual (Menstrual cup) Cutie Dose Ezy Dose Droppers 67082 and HEB Dropper 67082HB SILICONE MAGNETIC CONTAINERS ROSE 1CT 1/72 SILICONE MAGNETIC CONTAINERS CREAM 1CT 1/72 Silicone Pill Pouches SILICONE MAGNETIC CONTAINERS BUTTER 1CT 1/72 SILICONE MAGNETIC CONTAINERS WHITE 1CT 1/72 SILICONE MAGNETIC CONTAINERS TEAL 1CT 1/72 SILICONE MAGNETIC CONTAINERS 2CT 4/24 SILICONE MAGNETIC CONTAINERS SAGE 1CT 1/72 SILICONE MAGNETIC CONTAINERS PEACH 1CT 1/72 SILICONE MAGNETIC CONTAINERS PERIWINKLE 1CT 1/72 SILICONE MAGNETIC CONTAINERS BLACK 1CT 1/72 SILICONE MAGNETIC CONTAINERS RAINBOW 7CT 1/72

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HHE	Cup, Menstrual	Obstetrics/Gynecology	Class 2	884.5400	2024-02-13
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2021-10-22
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2024-02-13
KCM	Dropper, Ent	Ear, Nose, Throat	Class 1	874.5220	2025-01-13
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2022-02-24

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Shenzhen Kean Silicone Product Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K944481	Garan Scientific, Inc.	THE HEART PROTECTOR	1995-04-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009881291. Last updated year: 2026. Please use registration number 3009881291 when referencing this establishment in official correspondence.