Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023007429

FEI Number

3023007429

Entity Name

GOODMI INTELLIGENT (SHENZHEN) CO.,LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Room 303, Building 12, Fuqiao Second District, Heping Community, Fuhai Street, Bao'an District, Shenzhen Guangdong 518100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Goodmi Intelligent (Shenzhen) Co.,Ltd. (Owner Number: 10091158)

Owner / Operator Contact Address

Room 303, Building 12, Fuqiao Second District, Heping Community, Fuhai Street, Bao'an District, Shenzhen, CN-GD 518100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OSM ITE Digital Hearing Aids:GM-603A,GM-613A,GM-623A,GM-633A,GM-643A,GM-653A,GM-663A,GM-673A,GM-683A,GM-693A OSM BTE Digital Hearing Aids:GM-213A,GM-223A,GM-233A,GM-243A,GM-253A,GM-263A,GM-273A,GM-283A,GM-293A OSM BTE Digital Hearing Aids:GM-103A,GM-113A,GM-123A,GM-133A,GM-143A,GM-153A,GM-163A,GM-173A,GM-183A,GM-193A,GM-203A ESD Hearing Aids

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OSM	Hearing Aid, Air-Conduction With Wireless Technology, Prescription	Ear, Nose, Throat	Class 2	874.3305	2024-07-15
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2024-07-15

Official Correspondent

Lestlie Li

US Agent Details

Christine Wang Email: Christinewang614@gmail.com Phone: (918) 9988916

Related Public Records

Same Entity

Goodmi Intelligent (Shenzhen) 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
K892457	Telstar Electronics, Inc.	TELSTAR MODEL 1/3 ITE HEARING AID	1989-06-06
K760996	Unitron Industries, Inc.	HEARING AID (MODEL 695D, 905 & 960P)	1976-11-16
K840825	Maico Hearing Instruments, Inc.	SERIES MR IN-THE-EAR CUSTOM HEARING AID	1984-03-30
K946253	Maico Hearing Instruments, Inc.	MAICO IN-THE-EAR MODEL RD 201	1995-01-30
K863975	Gn Danavox, Inc.	CUSTOM IN-THE-EAR	1986-11-07

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3015965752	HANA MICROELECTRONICS (CAMBODIA) CO., LTD.	Koh Kong Province, KH
3030682076	ELEHEAR INC.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023007429. Last updated year: 2026. Please use registration number 3023007429 when referencing this establishment in official correspondence.