Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016587556

FEI Number

3016587556

Entity Name

ZHONGSHAN XIAOLAN TOWN SENLAN ELECTRONIC FACTORY

City/State/Country

Zhongshan City Guangdong, CN

Establishment Address

2/F, Plant 3, No.39 of Jucheng Avenue East, Xinshi Community, Xiaolan Town, Zhongshan City Guangdong 528415, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zhongshan XiaoLan Town SenLan Electronic Factory (Owner Number: 10082358)

Owner / Operator Contact Address

2/F, Plant 3, No.39 of Jucheng Avenue East, Xinshi Community, Xiaolan Town, Zhongshan City, Zhongshan City, CN-GD 528415, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K252669

PMA Number

N/A

All Registered Proprietary Names

HEARING AIDS A-130B;A-208B;F-135B;F-136B;F-138TB;F-139B;F-998B;V-168B;K-100;K-108;K-200;K-208;K-300;K-303;F-16;F-28;V-68;V-99 HA201/K-98/HAT605/HAT606/HAT607/HAT608/A-381/A-382/A-383/A-383/A-360/A-130/A-318/A-133/F-998/V-188/K-89/A-208B A1-D1, A1-D2, A2-DA, A2-D2, A2-D3, A3-G1T, A3-G2T, A6-G1T, A6-G2T, A6-G3T, A6-G F-139/F-136/V-163/F-137/B-13/V-168/F-138/X-168/V-185/V-183/V-188B/V-263PB/F-998B/E-103/B-18/B-19/K-80/K-82/K-86/K-188/K-88/X-136 A-90; G5; G6 A-209D Hearing Aid F-18/F-28/V-68/F-16/V-99/A-155/C-108/C-109/A-80/A-60/E-9/D-322/D-303/A-111/B-63/F-22/A-360/A-318/K-89/F-135B/A-208/V-168B/V-189B/A-130 Fetal Doppler, U8-25, U9-25

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	2021-07-15
QUF	Hearing Aid, Air-Conduction, Over The Counter	Ear, Nose, Throat	Class 1	874.3300	2022-12-29
KNG	Monitor, Ultrasonic, Fetal	Obstetrics/Gynecology	Class 2	884.2660	2026-04-03

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

Zhongshan XiaoLan Town SenLan Electronic Factory

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 3016587556. Last updated year: 2026. Please use registration number 3016587556 when referencing this establishment in official correspondence.