Data / Medical devices / China / Shenzhen Micro Electric Intelligence Co., Ltd.
Shenzhen Micro Electric Intelligence Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance
Shenzhen Micro Electric Intelligence Co., Ltd. is registered with the FDA (registration 3018975080) in Shenzhen Guangdong, China. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 2, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018975080
- Address
- 2nd Floor, Building 11, Block A, First industrial zone of Gonghe,hajing, Bao'an District, Shenzhen Guangdong, China, 518104
- Owner or operator
- Shenzhen Micro Electric Intelligence Co., Ltd. (10093098)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- March 29, 2025
- Registered through
- 2026
- Brand names listed
- 4 Replaceable Heads,WD-JY-W001, Dental calculus remover;with LED Light & 5 Modes, Rechargeable Dental Cleaner,, Plaque Remover for Teeth,Dental Cleaning Kit Tartar Remover for Teeth,UItrasonic Electric Dental Scaler, Ultrasonic Scaler, WD-JY-A005, WD-JY-H009, WD-JY-10011, WD-JY-K0012,, WD-JY-G004, WD-JY-C006, WD-JY-M0014, WD-JY-N0015,, WD-JY-K0013, WD-JY-K0014, WD-JY-K0015, WD-JY-K0016, WD-JY-L0013, WD-JY-L0014, WD-JY-L0015, WD-JY-L0016,WD-JY-L0017 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Irrigator, Powered Nasal | KMA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pad, Heating, Powered | IRT | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pick, Massaging | JET | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Scaler, Periodontic | EMN | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Scaler, Ultrasonic | ELC | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Toothbrush, Powered | JEQ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Unit, Oral Irrigation | EFS | 1 | 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 |
|---|---|---|---|---|---|---|
| July 2, 2024 | K240707 | Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017) | ELC | Substantially Equivalent | Shenzhen Micro Electric Intelligence Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Toothbrush, Powered
- All makers of Pick, Massaging
- All makers of Scaler, Ultrasonic
- All makers of Pad, Heating, Powered
- All makers of Unit, Oral Irrigation
- All makers of Irrigator, Powered Nasal
Updated July 2, 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.