Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030535004

FEI Number

3030535004

Entity Name

GUANGDONG JIAJIANLE TECHNOLOGY CO., LTD.

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

Room 320, 321, 322, 326 and 328, No.115, West Huanshi Avenue, Nansha District, Guangzhou Guangdong 510000, CN

Establishment Type(s)

Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Guangdong Jiajianle Technology Co., Ltd. (Owner Number: 10089836)

Owner / Operator Contact Address

Room 320, 321, 322, 326 and 328, No.115, West Huanshi Avenue, Nansha District, 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

BTE Hearing Aid (model: J-320B, J-321B, J-322B, J-323B, J-325B, J-326B) BTE Hearing Aid (model: J-307B, J-308B, J-309B, J-310B, J-311B, J-312B, J-313B, J-315B, J-316B, J-317B, J-318B, J-319B) BTE Hearing Aid (model: J-961DB, J-962DB, J-963DB, J-965DB, J-966DB, J-967DB, J-968DB, J-969DB, J-881DB, J-882DB) BTE Hearing Aid (model: J-883DB, J-885DB, J-886DB, J-887DB, J-888DB, J-889DB, J-301B, J-302B, J-303B, J-305B, J-306B) ITE Hearing Aid (model: J-210B, J-211B, J-212B, J-213B, J-215B, J-216B, J-217B, J-218B, T701B, T702B, T703B, T705B) Neckband Hearing Aid (model: L511B, L512B) ITE Hearing Aid (model: T706B, T707B, T708B, T709B, T710B, T711B, T712B, T713B, T715B, T716B, T717B) Neckband Hearing Aid (model: J-307, J-308, J-309, J-310, J-311) BTE Hearing Aid (model: J-961, J-962, J-963, J-965, J-966, J-967, J-968, J-969) BTE Hearing Aid (model: J-881, J-882, J-883, J-885, J-886, J-887, J-888, J-889) ITE Hearing Aid (model: J-212, J-213, J-215, J-216, J-217, J-218) Pocket Hearing Aid (model: J-101, J-102, J-103, J-105, J-106, J-107, J-108, J-109, J-110, J-111) BTE Hearing Aid (model: J-961B, J-962B, J-963B, J-965B, J-966B, J-967B, J-968B, J-969B, J-881B, J-882B, J-883B, J-885B) Neckband Hearing Aid (model: L501B, L502B, L503B, L505B, L506B, J-307B, L507B, L508B, L509B) Pocket Hearing Aid (model: J-101B, J-102B, J-103B, J-105B, J-106B, J-107B, J-108B, J-109B, J-110B, J-111B) ITE Hearing Aid (model: J-201B, J-202B, J-203B, J-205B, J-206B, J-207B) BTE Hearing Aid (model: J-608DB, J-609DB, J-610DB, J-611DB, J-612DB) BTE Hearing Aid (model: J-886B, J-887B, J-888B, J-889B, J-601DB, J-602DB, J-603DB, J-604DB, J-605DB, J-606DB, J-607DB)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QUG	Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	Ear, Nose, Throat	Class 2	874.3305	2024-01-11
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2024-01-11
OSM	Hearing Aid, Air-Conduction With Wireless Technology, Prescription	Ear, Nose, Throat	Class 2	874.3305	2024-01-11

Official Correspondent

No official correspondent registered.

US Agent Details

Linda Chen Business: Dynasty Medical Consulting Inc. Email: usagent@chonconn.com Phone: (832) 3809688

Related Public Records

Same Entity

Guangdong Jiajianle Technology 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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030535004. Last updated year: 2026. Please use registration number 3030535004 when referencing this establishment in official correspondence.