GUANGDONG ROMAN TECHNOLOGY CO., LTD

FDA Device Registration & Listing · Dongguan Guangdong, CN · Registration 3012803257

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012803257
FEI Number
3012803257
Entity Name
GUANGDONG ROMAN TECHNOLOGY CO., LTD
City/State/Country
Dongguan Guangdong, CN
Establishment Address
No.18 Xinguang Road, Jinhe District, Zhangmutou Town, Dongguan Guangdong 523628, CN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
GuangDong Roman Technology Co., Ltd (Owner Number: 10056757)
Owner / Operator Contact Address
No.18 Xinguang Road, Jinhe District, Zhangmutou Town, Dongguan, CN-GD 523628, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Vibrite Blue, TRI BEAM EDGE TOOTHBRUSH, POWERED, SonicYou, X20B NX7000, NX8000, NX9000 T28, T35, Burst Pro, Burst Curve SL-T5, T36, Burst Nova T25, PX-001, SOC-SPT, ST038, BURSTkids Sonic Toothbrush S54, Pro Brush Head, Curve Brush Head, S62, Nova brush head, S59, S630 Brush Heads SN01, SN02, S121, S112, S170, S190, SK23, S070, S410, SC01, SC02, SC03, S560, Toothbrush sterilisation case: U8, UV Sterilizer, PX-UV1

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EEG Heat Source For Bleaching Teeth Dental Class 1 872.6475 2024-08-02
JEQ Toothbrush, Powered Dental Class 1 872.6865 2018-01-12
EFW Toothbrush, Manual Dental Class 1 872.6855 2019-09-02

Official Correspondent

Youchun Yan

US Agent Details

Wilson Li Business: REPF America LLC Email: qagujdsvvt@outlook.com Phone: (719) 2013315

Related Public Records

Same Entity

GuangDong Roman Technology 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012803257. Last updated year: 2026. Please use registration number 3012803257 when referencing this establishment in official correspondence.
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