Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021316061

FEI Number

3021316061

Entity Name

Shenzhen Alex Technology Co., Ltd.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

7th Floor, Building B, Tangxi Zhigu, Xijing Road, Xixiang, Baoan, Shenzhen Guangdong 518102, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Shenzhen Alex Technology Co., Ltd. (Owner Number: 10083469)

Owner / Operator Contact Address

7th Floor, Building B, Tangxi Zhigu, Xijing Road, Xixiang, Baoan, Shenzhen, CN-GD 518102, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Eustachian Tube Unclogger, BOETU01 BoneHearing F23, BoneHearing F18, BoneHearing F19, BoneHearing F21S BoneHearing F8A, BoneHearing F8B, BoneHearing F8C, Bocoolife Clarity One, Bocoolife Clarity Pro BoneHearing F2D, BoneHearing F2E, BoneHearing F2F, BoneHearing F2G, BoneHearing F2H; Hearing Aids, BoneHearing F24 Hearing Aids, Over The Counter, BoneHearing F2, BoneHearing F2A, BoneHearing F2B, Hearing Aids, BoneHearing F15 BoneHearing F25; Hearing Aids, BoneHearing F2C, BoneHearing F2Y, BoneHearing F9, BoneHearing F10, HearBoost F11 HearBoost F12; Hearing Aids, BoneHearing F2J, BoneHearing F2K, BoneHearing F20, BoneHearing F21, BoneHearing F22 Ear Dryer, KHEDE01, KHEDE02, KHEDE03, KHEDE04 Ear Dryer Tips, BOEDE06, BOEDE10 Electric Ear Cleaner Tips, BOEWE015, BOEWE030, BOEWE060, BOEWE0100 Ear Washer Tips, BOEW030, BOEW060, BOEW0100 Electric Ears Cleaner, BOEWE04, BOEWE06, BOEWE07, BOEWE08 Ear Washer, BOEW011, BCEB0121, BCEW03, BOEW011-CO, BCEW04, BCEW04-30, BCEW05, BCEW06, BCEW07 Electric Ear Cleaner, Electric Ear Wax Removal, BOEWE01, BOEWE02, BOEWE03 Ear Pressure Relief, BOEPR02 Ear Pain Relief, BOEPR01 Middle Ear Inflation Device, BOMEID01 Ears Cleaner with Camera, BOEWEC01

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GBY	Catheter, Eustachian, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2023-12-28
QUF	Hearing Aid, Air-Conduction, Over The Counter	Ear, Nose, Throat	Class 1	874.3300	2026-01-08
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2023-12-28
OGQ	Ear Irrigation Kit	General Hospital	Class 1	880.6960	2021-11-23
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2023-12-28
JYT	Pick, Microsurgical Ear	Ear, Nose, Throat	Class 1	874.4420	2023-12-28

Official Correspondent

Serena Xie

US Agent Details

Aokai Tang Business: AOKT STUDIO LLC Email: aokt-service@outlook.com Phone: (757) 2240177

Related Public Records

Same Entity

Shenzhen Alex 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 3021316061. Last updated year: 2026. Please use registration number 3021316061 when referencing this establishment in official correspondence.