Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021456527

FEI Number

3021456527

Entity Name

Eran Technology (Shenzhen)Co.,Limited

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

301,BldgA4,Silicon Valley Power SZ Low-Carbon Tech Demo Park, No. 35, DafuRd, Zhangge Comm, Fucheng Sub-dist, Shenzhen Guangdong 518100, CN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Eran Technology (Shenzhen) Co.,Limited (Owner Number: 10086736)

Owner / Operator Contact Address

301,BldgA4,Silicon Valley Power SZ Low-Carbon Tech Demo Park, No. 35, DafuRd, Zhangge Comm, Fucheng Sub-dist, Shenzhen, CN-GD 518100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TC1600-02J TC1600-03J TC1600-04J TC1600-08J TC1600-09J TC1600-11J TC1600-15J Mebak S3 JLH2 WA-A7 Viva Hear MC02 WA-A1 InsisCare 99404876 TC1600-N12 99047356 99404876 WA-Z1 WA-Z18 FT-O04 TC1600-P19 FT-O06 DAB006 BH55 BH-R55 ER02 JLH1 WD-G03-01 TC1600-02Y TC1600-03Y TC1600-04Y TC1600-08Y TC1600-09Y TC1600-11Y TC1600-15Y FT-09E FT-09F FT-03B FT-15A FT-04A WA-A12 WA-A2 WA-A6 Viva Hear MG03 WA-Z28 WA-A8 Viva Hear MH03 TC1600-O01 FT-O05 Alsophila 99047356 TC1600 TC1600-P16 TC1600-P23 TC1600-P24 TC1600-N8 TC1600-N11 TC1600-N15 TC1600-B09 TC1600-B03 TC1600-P17 TC1600-O03 TC1600-P25

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QUF	Hearing Aid, Air-Conduction, Over The Counter	Ear, Nose, Throat	Class 1	874.3300	2023-04-10
QUG	Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	Ear, Nose, Throat	Class 2	874.3305	2022-12-06

Official Correspondent

Suhua Nie

US Agent Details

Maple Chen Business: GVM Medical LLC Email: info@gvmmedical.com Phone: (610) 4517988

Related Public Records

Same Entity

Eran Technology (Shenzhen) Co.,Limited

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 3021456527. Last updated year: 2026. Please use registration number 3021456527 when referencing this establishment in official correspondence.