Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018999226

FEI Number

3018999226

Entity Name

MINAMI MEDICAL TECHNOLOGY (GUANGDONG) CO.,LTD.

City/State/Country

Zhongshan Guangdong, CN

Establishment Address

3F,No.13,Maonan Road,Torch Decelopment Zone, Zhongshan Guangdong 528400, CN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Foreign Private Label Distributor

Owner / Operator

Minami Medical Technology (Guangdong) Co.,Ltd. (Owner Number: 10081492)

Owner / Operator Contact Address

3F,No.13,Maonan Road,Torch Decelopment Zone, Zhongshan, CN-GD 528400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hearing Aid MA-BTE-P001;Vega p;Vega sp;Vocal P Pro;Vocal SP Pro;Virgo P Pro;Virgo SP Pro Linlok DHP; Linwin HP; M2219 M2231 ;Hearing Aid HA-11;HA-12; HA-13; HA-14; HA-21; HA-22; HA-23; HA-24; HA-31; HA-32; HA-33; HA-34; Hearing Aid ; PX5P;M2212C;M2214C ;M2215C; M2215F; M2216C; M2216F ;M2217A;M2217B; PX1P,PX2P,PX3P, Hearing Aid;Wireless Air-Conduction Hearing Aid;M2212B M3111,M3112,M3113,M3114,M3116,M3117,M3118,PX1M,PX2M,PX3M,PX4M,PX5M,PX6M, less Air-Conduction Hearing Aid M3119;Wireless Air-Conduction Hearing Aid M2212; M2214; M2214B; wireless Air-Conduction Hearing Aid M2215A ;M2215B;M2215D;M2215E; M2216A;M2216B;M2216D;M2216E Sunglassses ,iGlass-3S,FM i3 ,FMi32BKSMS1,FMi32TTFBS1,FMi33BKSM02;

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2021-04-20
QUG	Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	Ear, Nose, Throat	Class 2	874.3305	2023-05-23
OSM	Hearing Aid, Air-Conduction With Wireless Technology, Prescription	Ear, Nose, Throat	Class 2	874.3305	2022-11-01
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2025-02-25

Official Correspondent

No official correspondent registered.

US Agent Details

peter yang Business: JIAMEI CONSULTING INC. Email: info@jiameiconsulting.com Phone: (310) 2168437

Related Public Records

Same Entity

Minami Medical Technology (Guangdong) 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

Similar Registrations

Registration Number	Establishment Name	Location
3008713760	KENYON AUDIOLOGY	Bend, OR, US
3022507139	Zhongrui HearJoy Medical Equipment co., Ltd.	Shenzhen Guangdong, CN
3005785669	ALPS INTERNATIONAL	NEW DELHI, IN
2523819	MICROSONIC, INC.	AMBRIDGE, PA, US
3017618900	HUIZHOU GOLD ROSE TECHNOLOGY CO.,LTD	huizhou Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018999226. Last updated year: 2026. Please use registration number 3018999226 when referencing this establishment in official correspondence.