Manufacturer registered with FDA
Medcodes Healthcare (Shenzhen) Limited
Shenzhen, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 6
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1China
Devices listed with FDA
What Medcodes Healthcare (Shenzhen) Limited currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | medcodes W10, medcodes W20, medcodes W30, medcodes W40Teeth Bleaching Light W1001, W3001, W4002, W4003Teeth Whitening Strip WS301, WS401W4009,W4019,W4011,W4018,W4010,W4017,W4015,W4016,W4260,W4280 | 2022 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Lister | Sonic Electric Toothbrush L1Sonic electric toothbrush X-3 | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MEDCODES HEALTHCARE (SHENZHEN) LIMITEDFDA reg. 3025428426 | Shenzhen Guangdong, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10086499). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.