Data / Medical devices / China / Chafon Technology Co., Limited
Chafon Technology Co., Limited: FDA-registered device maker in TSIM SHA TSUI Hong Kong, China, 1 510(k) clearance
Chafon Technology Co., Limited is registered with the FDA (registration 3043165985) in TSIM SHA TSUI Hong Kong, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 30, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3043165985
- Address
- Room 1,16/F Empress Plaza 17-19 Chatham Road South, TSIM SHA TSUI Hong Kong, China, 999077
- Owner or operator
- CHAFON TECHNOLOGY CO., LIMITED (10094897)
- Roles
- Exporter to the US
- First device listed
- January 4, 2026
- Registered through
- 2026
- Brand names listed
- Baby Nasal Aspirator: N1, N2, N3, N4, Wearable Breast Pump: YM-801, YM-803, YM-805, YM-806, YM-808
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bottle, Collection, Vacuum | KDQ | 2 | Exporter to the US | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| August 30, 2024 | K231969 | BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808) | HGX | Substantially Equivalent | Dongguanshi Yiyingmei Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 30, 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.