FDA Registration
Active
🇨🇳 China
Shenzhen Alex Technology Co., Ltd.
Reg #: 3021316061
·
FEI: 3021316061
·
Expires 2026
Products
7
Proprietary Names
19
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- Shenzhen Alex Technology Co., Ltd.
- Registration Number
- 3021316061
- FEI Number
- 3021316061
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7th Floor, Building B, Tangxi Zhigu, Xijing Road, Xixiang, Baoan
- City
- Shenzhen Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Shenzhen Alex Technology Co., Ltd.
- Operator Number
- 10083469
- Address
- 7th Floor, Building B, Tangxi Zhigu, Xijing Road, Xixiang, Baoan
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518102
- Country
- CN
- Correspondent
- Serena Xie
US Agent
- Business Name
- AOKT STUDIO LLC
- Contact Name
- Aokai Tang
- Address
- 105 W Welling Ave
- City
- Pennington
- State
- NJ
- ZIP
- 08534
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Eustachian, General & Plastic Surgery | GBY | Class 1 | General, Plastic Surgery | No | 2023-12-28 |
| Hearing Aid, Air-Conduction, Over The Counter | QUF | Class 1 | Ear, Nose, Throat | No | 2026-01-08 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2023-12-28 |
| Ear Irrigation Kit | OGQ | Class 1 | General Hospital | No | 2021-11-23 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2023-12-28 |
| Pick, Microsurgical Ear | JYT | Class 1 | Ear, Nose, Throat | No | 2023-12-28 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2023-12-28 |
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
Otoscope, BOEWE05
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device