KUNWEI MEDICAL ELECTRONICS CO.,LTD

FDA Device Registration & Listing · Shenzhen Guangdong, CN · Registration 3017903826

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3017903826
FEI Number
3017903826
Entity Name
KUNWEI MEDICAL ELECTRONICS CO.,LTD
City/State/Country
Shenzhen Guangdong, CN
Establishment Address
Room 1402, Block B, Building 2, Longgang Tianan Cyber Park, Huangge Road, Longgang District, Shenzhen Guangdong 518172, CN
Establishment Type(s)
Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Kunwei Medical Electronics Co.,Ltd (Owner Number: 10078957)
Owner / Operator Contact Address
Room 1402, Block B, Building 2, Longgang Tianan Cyber Park, Huangge Road, Longgang District, Shenzhen, CN-GD 518172, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Hearing Aids: KV-601, KV-602, KV-603, KV-701, KV-702, KV-703, KV-801, KV-802, KV-803, KV-901, KV-902, KV-903 Hearing Aids: KV-201, KV-202, KV-203, KV-301,KV-302, KV-303, KV-401, KV-402, KV-403,KV-501, KV-502, KV-503 In-The-Ear Hearing Aid, model: KG-71B,KG-73B,KG-75B,KG-76B,KG-77B,KG-78B,KG-79B Behind-The-Ear Hearing Aid, model: KD-17B,KD-27B,KD-37B,KD-57B,KD-67B,KD-87B,KD-97B,KV-306B,KV-307B,KV-308B,KV-309B

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 2020-11-12
QUG Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter Ear, Nose, Throat Class 2 874.3305 2022-12-07

Official Correspondent

Kenson Zhao

US Agent Details

Noah Zhang Business: HyperCert Limited Email: hycerfda@hycerglobal.com Phone: (863) 3233636

Related Public Records

Same Entity

Kunwei Medical Electronics 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 3017903826. Last updated year: 2026. Please use registration number 3017903826 when referencing this establishment in official correspondence.
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