Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3037001880

FEI Number

3037001880

Entity Name

ZHONGSHAN TIANLE HEARING TECHNOLOGY CO.,LTD

City/State/Country

Zhongshan Guangdong, CN

Establishment Address

No.1 Jucheng Road Middle, Xiaolan Town, Zhongshan City, Guangdong Province, Zhongshan Guangdong 528415, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zhongshan Tianle Hearing Technology Co.,Ltd (Owner Number: 10092762)

Owner / Operator Contact Address

No.1 Jucheng Road Middle, Xiaolan Town, Zhongshan City, Guangdong Province, Zhongshan, CN-GD 528415, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

In The Canal Hearing Aid/TL-315M, TL-316M, TL-317M, TL-318M, TL-319M, TL-515M, TL-516M, TL-518M, TL-519M Body-worn Hearing Aid/HA-9812M, HA-9816M, HA-9826M, HA-9813M, HA-9828M, HA-93CM, HA-9858M Completely In Canal Hearing Aid/TS-6112M, TS-6113M, TS-6115M, TS-6116M, TS-6118M, TS-6119M, TS-6120M, TS-6212M Neckband Heairng Aid/TL-633M, TL-635M, TL-636M, TL-638M, TL-639M, TL-650M, TL-651M, TL-652M Invisible In The Canal Hearing Aid/TY-8001M, TY-8002M, TY-8003M, TY-8005M, TY-8006M, TY-8008M, TY-8009M, TY-8010M Behind The Ear Hearing Aid/TL-007AM, TL-008AM, TL-009AM, TL-115M, TL-112M, TL-113M, TL-116M, TL-117M, TL-118M In The Ear Hearing Aid/TF-950M, TF-951M, TF-952M, TF-953M, TF-955M, TF-956M, TF-957M, TF-958M, TF-959M Invisible In The Canal Hearing Aid/TY-8011M, TY-8012M, TY-8013M, TY-8015M, TY-8016M, TY-8018M Completely In Canal Hearing Aid/TS-6213M, TS-6215M, TS-6216M, TS-6218M, TS-6219M, TS-6220M, TS-6226M Behind The Ear Hearing Aid/TE-113M, TE-115M, TE-116M, TE-119M, TE-200M, TE-211M, TE-212M, TE-213M Neckband Heairng Aid/TL-621M, TL-622M, TL-623M, TL-625M, TL-626M, TL-628M, TL-629M, TL-630M, TL-631M, TL-632M In The Canal Hearing Aid/TW-912M, TW-913M, TW-915M, TW-916M, TW-918M, TW-919M, TW-920M In The Canal Hearing Aid/TW-811M, TW-812M, TW-813M, TW-815M, TW-816M, TW-818M, TW-819M, TW-911M In The Ear Hearing Aid/TF-960M, TF-961M, TF-962M, TF-963M, TF-964M, TF-965M, TF-966M, TF-968M In The Canal Hearing Aid/TL-211M, TL-212M, TL-213M, TL-216M, TL-218M, TL-219M, TL-311M, TL-312M, TL-313M Body-worn Hearing Aid/HA-93M, HA-95M, HA-96M, HA-98M, HA-9818M, HA-9825M, HA-9822M, HA-9829M Behind The Ear Hearing Aid/TL-119M, TL-611M, TL-612M, TL-613M, TL-615M, TL-616M, TL-617M, TL-618M Behind The Ear Hearing Aid/TE-002M, TE-003M, TE-004M, TE-005M, TE-006M, TE-007M, TE-008M, TE-009M, TE-112M Invisible In The Canal Hearing Aid/TY-8001G, TY-8002G, TY-8003G, TY-8005G, TY-8006G, TY-8008G, TY-8009G, TY-8010G Behind The Ear Hearing Aid/TL-007AG, TL-008AG, TL-009AG, TL-115G, TL-112G, TL-113G, TL-116G, TL-117G, TL-118G, TL-119G In The Canal Hearing Aid/TW-913G, TW-915G, TW-916G, TW-918G, TW-919G, TW-920G Completely In Canal Hearing Aid/TS-6112G, TS-6113G, TS-6115G, TS-6116G, TS-6118G, TS-6119G, TS-6120G, TS-6212G, TS-6213G Behind The Ear Hearing Aid/TL-611G, TL-612G, TL-613G, TL-615G, TL-616G, TL-617, G, TL-618G Body-worn Hearing Aid/HA-9816G, HA-9826G, HA-9813G, HA-9828G, HA-93CG, HA-9858G Neckband Heairng Aid/TL-635G, TL-636G, TL-638G, TL-639G, TL-650G, TL-651G, TL-652G Neckband Heairng Aid/TL-621G, TL-622G, TL-623G, TL-625G, TL-626G, TL-628G, TL-629G, TL-630G, TL-631G, TL-632G, TL-633G Behind The Ear Hearing Aid/TE-115G, TE-116G, TE-119G, TE-200G, TE-211G, TE-212G, TE-213G In The Canal Hearing Aid/TW-811G, TW-812G, TW-813G, TW-815G, TW-816G, TW-818G, TW-819G, TW-911G, TW-912G In The Canal Hearing Aid/TL-211G, TL-212G, TL-213G, TL-216G, TL-218G, TL-219G, TL-311G, TL-312G, TL-313G, TL-315G In The Ear Hearing Aid/TF-950G, TF-951G, TF-952G, TF-953G, TF-955G, TF-956G, TF-957G, TF-958G, TF-959G, TF-960G Completely In Canal Hearing Aid/TS-6215G, TS-6216G, TS-6218G, TS-6219G, TS-6220G, TS-6226G Body-worn Hearing Aid/HA-93G, HA-95G, HA-96G, HA-98G, HA-9818G, HA-9825G, HA-9822G, HA-9829G, HA-9812G Behind The Ear Hearing Aid/TE-002G, TE-003G, TE-004G, TE-005G, TE-006G, TE-007G, TE-008G, TE-009G, TE-112G, TE-113G In The Canal Hearing Aid/TL-316G, TL-317G, TL-318G, TL-319G, TL-515G, TL-516G, TL-518G, TL-519G Invisible In The Canal Hearing Aid/TY-8011G, TY-8012G, TY-8013G, TY-8015G, TY-8016G, TY-8018G In The Ear Hearing Aid/TF-961G, TF-962G, TF-963G, TF-964G, TF-965G, TF-966G, TF-968G

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	2025-02-15
QUG	Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	Ear, Nose, Throat	Class 2	874.3305	2025-02-15

Official Correspondent

George Wang

US Agent Details

MicheIIe Yu Email: michelleyu@fudakang.com Phone: (725) 7266008

Related Public Records

Same Entity

Zhongshan Tianle Hearing 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 3037001880. Last updated year: 2026. Please use registration number 3037001880 when referencing this establishment in official correspondence.