Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038201798

FEI Number

3038201798

Entity Name

GZ CHUANGQI MEDICAL TECH CO., LTD.

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

Room 518, Tower G3, 39Ruihe Road, Science Town, Huangpu District, Guangzhou, China, Guangzhou Guangdong 510000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GZ Chuangqi Medical Tech Co., Ltd. (Owner Number: 10093177)

Owner / Operator Contact Address

Room 518, Tower G3, 39Ruihe Road, Science Town, Huangpu District, Guangzhou, China, Guangzhou, CN-GD 510000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Inbracket, Customized Labial Self-ligating Bracket, Inbracket-B Inbracket, Customized Lingual Self-ligating Bracket, Inbracket-S Inbracket, Customized Lingual Self-ligating Bracket, Inbracket-LS Inbracket, Customized Lingual Bracket, Inbracket-L

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2025-04-10

Official Correspondent

Junrong Liang

US Agent Details

Tang Thomas Email: usagent@cefda.com Phone: (631) 7511103

Related Public Records

Same Entity

GZ Chuangqi Medical Tech 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
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13

Similar Registrations

Registration Number	Establishment Name	Location
3010462491	DW Lingual Systems GmbH	Bad Essen Lower Saxony, DE
3009257060	Ortho Traction Pads	Norwalk, CT, US
3027343382	UNIVY TECHNOLOGY ADVANCED CO. LTD	Shanghai, CN
3023443842	HENAN BAISTRA MEDICAL DEVICES LIMITED	Zhengzhou Henan, CN
3012232878	SUNSTAR TRADING INTERNATIONAL LIMITED	Kowloon Hong Kong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038201798. Last updated year: 2026. Please use registration number 3038201798 when referencing this establishment in official correspondence.