Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023346034

FEI Number

3023346034

Entity Name

COMEBETTER (GUANGZHOU) TECHNOLOGY CO., LTD

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

NO. 20, Chuangzhi Building, NO. 63, Chuangqi Road, Shilou Town, Panyu District, Guangzhou, Guangzhou Guangdong 511450, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ComeBetter (Guangzhou) Technology CO., LTD (Owner Number: 10085403)

Owner / Operator Contact Address

NO. 20, Chuangzhi Building, NO. 63, Chuangqi Road, Shilou Town, Panyu District, Guangzhou, Guangzhou, CN-GD 511450, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

D474825 Splint, extremity, non-inflatable, external, non-sterile

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2022-06-14

Official Correspondent

Patty Yuan

US Agent Details

Melanie Leibowitz Business: Performance Health Supply Email: melanie.leibowitz@performancehealth.com Phone: (331) 6889688

Related Public Records

Same Entity

ComeBetter (Guangzhou) Technology CO., LTD

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 3023346034. Last updated year: 2026. Please use registration number 3023346034 when referencing this establishment in official correspondence.