Data / Medical devices / China / Xiamen Amonmed Biotechnology Co., Ltd.
Xiamen Amonmed Biotechnology Co., Ltd.: FDA-registered device maker in Xiamen City Fujian, China, 1 510(k) clearance
Xiamen Amonmed Biotechnology Co., Ltd. is registered with the FDA (registration 3048342015) in Xiamen City Fujian, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 20, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3048342015
- Address
- Unit 74, 1st Floor, Building A19, Xiamen Biomedical Industrial Park No.2036 West Wengjiao Road, Haicang District, Xiamen City Fujian, China, 361026
- Owner or operator
- XIAMEN AMONMED BIOTECHNOLOGY CO., LTD. (10096139)
- Roles
- Exporter to the US
- First device listed
- July 7, 2026
- Registered through
- 2026
- Brand names listed
- LED Light Therapy Mask
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Light Based Over The Counter Wrinkle Reduction | OHS | 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 |
|---|---|---|---|---|---|---|
| December 20, 2024 | K243040 | LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418) | OHS | Substantially Equivalent | Shenzhen Siken 3D Technology Development Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated December 20, 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.