FDA Registration
Active
🇨🇳 China
AOJ HEALTH TECHNOLOGY CO., LTD.
Reg #: 3020994856
·
FEI: 3020994856
·
Expires 2026
Products
8
Proprietary Names
14
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- AOJ HEALTH TECHNOLOGY CO., LTD.
- Registration Number
- 3020994856
- FEI Number
- 3020994856
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Building No.1,1-3F, Building No.2,2F, AOJ Industrial Park, Sanwei Community, Hangcheng Street, Baoan District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K233913
Owner / Operator
- Firm Name
- AOJ HEALTH Technology Co., Ltd.
- Operator Number
- 10084496
- Address
- Building No.1,1-3F, Building No.2,2F, AOJ Industrial Park, Sanwei Community, Hangcheng Street, Bao'an District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518126
- Country
- CN
- Correspondent
- Jack Wang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Irrigator, Powered Nasal | KMA | Class 1 | Ear, Nose, Throat | No | 2025-07-02 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2026-04-28 |
| Pump, Breast, Powered | HGX | Class 2 | Obstetrics/Gynecology | No | 2024-09-02 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2023-10-26 |
| Cleaner, Denture, Mechanical | JER | Class 1 | Dental | No | 2024-09-05 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2023-11-22 |
| Pump, Breast, Non-Powered | HGY | Class 1 | Obstetrics/Gynecology | No | 2025-07-03 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2024-08-16 |
Proprietary Names
Atomizing Nasal Irrigator ANI-801, ANI-802, ANI-803, ANI-804
Nasal Aspirator ASP-401, Nasal Aspirator ASP-402
Electric Breast Pump (BRP-301, 302, 303, 304, 305, 306, 307, 308, 201, 202, 203)
Otoscope OT-503
Ear Wax Removal Tool Camera EWR-10, EWR-50
Otoscope OT-501
Ultrasonic Cleaner USC-10
Ultrasonic Cleaner USC-20
Insect Bite Healer IBR 10, IBR 20, IBR 30, IBR 40, IBR 50, IBR 60
Insect Bite Healer IB 50E, IB 80, IB 100, IB 150, IB 200,IB A50, IB 550
Insect Bite Healer IBR70, IBR75, IBR80, BR100, BR200, BR70, BR75, IBR600, IBR700, IBR800, IBR900
Manual Breast Pump BRP-101
Nasal Aspirator ASP-402
Nasal Aspirator ASP-401
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)