Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3037591931

FEI Number

3037591931

Entity Name

DOUBLE WHITE MEDICAL TECHNOLOGY DEVELOPMENT(GUANGZHOU) CO. LTD.

City/State/Country

GUANGZHOU Guangdong, CN

Establishment Address

Room 505, No. 222(Self-edited: 616)Jianshe North Road, Xinhua Street, Huadu District, GUANGZHOU Guangdong 510800, CN

Establishment Type(s)

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

Owner / Operator

Double White Medical Technology Development(Guangzhou) Co. L (Owner Number: 10093182)

Owner / Operator Contact Address

Room 505, No. 222(Self-edited: 616)Jianshe North Road, Xinhua Street, Huadu District, GUANGZHOU, CN-GD 510800, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Teeth Whitening Gel 2ml/ 3ml/ 5ml /10ml; Teeth Whitening Home Kit Teeth Whitening Kit; Teeth Whitening Pen; Teeth Whitening Pen-TWP-01 EEG Teeth Whitening Kit; Enlight Trading Inc.; Teeth Whitening Gel Charcoal Teeth Whitening Powder; CVS HEALTH TEETH WHITENING PEN; Dentiguard LED Teeth Whitening Kit; Teeth Whitening Dry Strips, Teeth Whitening Gel Strips, Teeth Whitening U-wraps,Teeth Whitening Strips Teeth Whitening Powder; Teeth Whitening System Teeth Whitening Gel Strips; Teeth Whitening Strips,Teeth Whitening U-wraps Charcoal Teeth Whitening Strips; CVSHealth Brilliant White Whitening Strips(Coconut flavor) Fitreno Teeth Whitening Strips-ONG-YT-01; Teeth Whitening Dry Strips CVSHealth Brilliant White Whitening Strips(Peach flavor); Dissolving Teeth Whitening Strips

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MAU	Eraser, Dental Stain	Dental	Class 1	872.6855	2025-04-10
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2025-04-17

Official Correspondent

Xiaoyi Xu

US Agent Details

James St. Wu Business: Humiss Inc. Email: fda-reg@humiss.com Phone: (720) 7595888

Related Public Records

Same Entity

Double White Medical Technology Development(Guangzhou) Co. L

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3037591931. Last updated year: 2026. Please use registration number 3037591931 when referencing this establishment in official correspondence.