Data / Medical devices / China / Aoj Health Technology Co., Ltd.
Aoj Health Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance
Aoj Health Technology Co., Ltd. is registered with the FDA (registration 3020994856) in Shenzhen Guangdong, China. It lists 9 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 14, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020994856
- Address
- Building No.1,1-3F, Building No.2,2F, AOJ Industrial Park, Sanwei Community, Hangcheng Street, Baoan District, Shenzhen Guangdong, China, 518126
- Owner or operator
- AOJ HEALTH Technology Co., Ltd. (10084496)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 26, 2023
- Registered through
- 2026
- Brand names listed
- 12-201 BABOO Nasal Aspirator ASP-402, Nasal aspirator ASP-301, Atomizing Nasal Irrigator ANI-801, ANI-802, ANI-803, ANI-804, Compressor Nebulizer, models NEB-CP01,NEB-CP03, NEB-CP04, NEB-MP01, NEB-MP02, NEB-MP03, NEB-MP04, NEB-MP05, CorDx @AL21, Insect Bite Healer, ACL21011IBR40, Ear Wax Removal Tool Camera EWR-10, EWR-50, Electric Breast Pump (BRP-301, 302, 303, 304, 305, 306, 307, 308, 201, 202, 203), Insect Bite Healer IB 50E, IB 80, IB 100, IB 150, IB 200,IB A50, IB 550, Insect Bite Healer IBR 10, IBR 20, IBR 30, IBR 40, IBR 50, IBR 60 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bottle, Collection, Vacuum | KDQ | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Catheters, Suction, Tracheobronchial | BSY | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Cleaner, Denture, Mechanical | JER | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Irrigator, Powered Nasal | KMA | 1 | Manufacturer | accessdata.fda.gov |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | 1 | Manufacturer | accessdata.fda.gov |
| Otoscope | ERA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Pad, Heating, Powered | IRT | 2 | Manufacturer | accessdata.fda.gov |
| Pump, Breast, Non-Powered | HGY | 1 | Manufacturer | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 14, 2024 | K233913 | Electric Breast Pump (BRP-301); Electric Breast Pump (BRP-302); Electric Breast Pump (BRP-303); Electric Breast Pump (BRP-304); Electric Breast Pump (BRP-305); Electric Breast Pump (BRP-306); Electric Breast Pump (BRP-307); Electric Breast Pump (BRP-308) | HGX | Substantially Equivalent | Aoj Health Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Cleaner, Denture, Mechanical
- All makers of Irrigator, Powered Nasal
- All makers of Pad, Heating, Powered
- All makers of Pump, Breast, Powered
- All makers of Catheters, Suction, Tracheobronchial
- All makers of Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Updated May 14, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.