Data / Medical devices / China / Shenzhen Jermei Medical Device Technology Co.,ltd
Shenzhen Jermei Medical Device Technology Co.,ltd: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance
Shenzhen Jermei Medical Device Technology Co.,ltd is registered with the FDA (registration 3016731115) in Shenzhen Guangdong, China. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 19, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3016731115
- Address
- RM201-202, 4th Bldg, Xian Yu Xing Industrial Zone, Yuhe Road, Gonghe Community, Shajing, Baoan District, Shenzhen Guangdong, China, 518100
- Owner or operator
- Shenzhen Jermei Medical Device Technology Co.,Ltd (10063042)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- March 15, 2020
- Registered through
- 2027
- Brand names listed
- Electric toothbrush, JM691, JM802, JM810, JM811, JM817, JM818, JM821 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Manufacturer | accessdata.fda.gov |
| Toothbrush, Powered | JEQ | 1 | Contract manufacturer, Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| September 19, 2025 | K244035 | Portable mesh nebulizer (JM821) | CAF | Substantially Equivalent | Shenzhen Jermei Medical Device Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Massager, Therapeutic, Electric
- All makers of Toothbrush, Powered
- All makers of Nebulizer (Direct Patient Interface)
Updated September 19, 2025. 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.