SHENZHEN EARTECH COMPANY LTD.

FDA Device Registration & Listing · Shenzhen Guangdong, CN · Registration 3019872458

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
3019872458
FEI Number
3019872458
Entity Name
SHENZHEN EARTECH COMPANY LTD.
City/State/Country
Shenzhen Guangdong, CN
Establishment Address
4-516, Tusincere Science Park, Qingchun Road, Longcheng Street, Longgang, Shenzhen Guangdong 518000, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Shenzhen Eartech Company Ltd. (Owner Number: 10092207)
Owner / Operator Contact Address
4-516, Tusincere Science Park, Qingchun Road, Longcheng Street, Longgang, Shenzhen, CN-GD 518000, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Behind-the-ear hearing aid(model:ZTQ01ZT, ZTQ01ZT Pro,ZTQ02ZT, ZTQ02ZT Pro, ZTQ03ZT ZTQ03ZT Pro, ZTQ04ZT,ZTQ04ZT Pro) In-the-ear hearing aid(model: Sara 1, Sara 2, Sara 3, Sara 4,Sara 5, Sara 6, Sara 7, Sara 8, Sara 9, Sara 10) Behind-the-ear hearing aid (model: ZTQ05ZT, ZTQ05ZTPro) In-the-ear hearing aid(model: Sara 1, Sara 2, Sara 3, Sara 4, Sara 5, Sara 6, Sara 7, Sara 8, Sara 9, Sara 10) Behind-the-ear hearing aid (model: ZTQ05ZT, ZTQ05ZT Pro) Behind-the-ear hearing aid(model:ZTQ01ZT, ZTQ01ZT Pro, ZTQ02ZT, ZTQ02ZT Pro, ZTQ03ZT ZTQ03ZT Pro, ZTQ04ZT, ZTQ04ZT Pro)

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 2025-02-10
OSM Hearing Aid, Air-Conduction With Wireless Technology, Prescription Ear, Nose, Throat Class 2 874.3305 2024-12-12

Official Correspondent

zhongyi deng

US Agent Details

Clare Ho Business: SHARE INFO INC. Email: cfrhealthcare@foxmail.com Phone: (929) 4102964

Related Public Records

Same Entity

Shenzhen Eartech Company 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 3019872458. Last updated year: 2026. Please use registration number 3019872458 when referencing this establishment in official correspondence.
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