Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020998569

FEI Number

3020998569

Entity Name

XIAMEN REALINK HEARING TECHNOLOGY CO., LTD

City/State/Country

XIAMEN Fujian, CN

Establishment Address

Rm. B805, Jianye Bld, No.96, XIANGXING rd, Xiang'an TORCH HI-TECH ZONE,, XIAMEN Fujian 361021, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Xiamen Realink Hearing technology Co., Ltd (Owner Number: 10089694)

Owner / Operator Contact Address

Rm. B805, Jianye Bld, No.96, XIANGXING rd, Xiang'an TORCH HI-TECH ZONE,, XIAMEN, CN-FJ 361021, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pockettio HP, Dynamic Li, Dynamic BT Li, Startone 10, Clear108, GoodSound Pro, USB Charging ITC, Anese 313, Arena Pro series, iHear Pro, Nano Q Li, Pockettio Pro, Shine CIC BT-Li, UniSound RIC60, SmartEar Li, Pockettio DHP, iEarton OA Li, iEarton 13Pro, iEarton 675Pro, iEarton MCIC, iEarton RIC312, RIC10, iEarton RIC-Pro, Hearing aid, air conduction:Realink R BT-Li, Vivo2, Vivo111, Vivo9SP, Earlink 13P, Anese 315, iEarton RIC80, iEarton MCIC10, SmartEar Pro Realink FP-Pro, iEarton FP CIC 100, iEarton FP Pro CIC 600, Earlink FP-Pro, Nano Q FP-Pro, Ecoute FP-Pro, UniSound FP-Pro, Vivo FP, Starry FP-Pro, Shine FP-Pro, Starry CIC Face plate hearing aid :Faceplate hearing aid, ARENA FP-Pro, iHear FP-Pro, Realink R BT-Li, Starry CIC BT, Shine CIC BT, UniSound Li, MCIC 10, Pockettio DHP Li, Pockettio HP Li, Dynamic Li, HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY, OVER THE COUNTER: Dynamic BT Li, Earlink BT Li, GoodSound Pro, SmartEar Pro, Pockettio Pro, SmartEar Li, SmartEar Pro Li iEarton FP CIC, iEarton FP ITC, Earlink FP CIC, Earlink FP ITC, iEarton FP-Pro, iEarton FP-BT, iEarton FP-R, Arena Pro series, iHear Pro, Nano Q Li, SmartEar Pro Li, Comma, UniSound RIC60, SmartEar Pro, Pockettio DHP, hearing aid air conduction, Over-the-counter hearing aid:R BT-Li, Vivo2, Vivo111, Vivo9SP, Vivo Fun, Earlink 13P, Pockettio HP, Dynamic Li, Dynamic BT Li, SmartEar Li, Clear108, Pockettio Pro Li, USB Charging ITC Earlink OA Li, iEarton OA Li, iEarton 13Pro, iEarton 675Pro, iEarton MCIC, iEarton RIC312, RIC10, iEarton RIC-Pro,

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	2023-12-29
LRB	Face Plate Hearing Aid	Ear, Nose, Throat	Class 1	874.3300	2023-12-29
QUG	Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	Ear, Nose, Throat	Class 2	874.3305	2023-12-29
QUF	Hearing Aid, Air-Conduction, Over The Counter	Ear, Nose, Throat	Class 1	874.3300	2023-12-29

Official Correspondent

HUIMIN WANG

US Agent Details

Dan Yuan Email: service20210328@hotmail.com Phone: (805) 3513020

Related Public Records

Same Entity

Xiamen Realink Hearing 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

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 3020998569. Last updated year: 2026. Please use registration number 3020998569 when referencing this establishment in official correspondence.