Manufacturer registered with FDA
Zhejiang Eksen Medical Technology Co., Ltd
Huzhou, China. Lists 9 dental device types with FDA across 1 registered establishment.
- Device types listed
- 9
- Brands and models
- 11
- 510(k) clearances
- 0as applicant
- Markets registered in
- 657 registrations outside the US
- Establishments
- 1China
Registered in 6 markets
Where regulators' registries name Zhejiang Eksen Medical Technology Co., Ltd as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Zhejiang Eksen Medical Technology Co., Ltd | 9 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Zhejiang Eksen Medical Technology Co.,Ltd. | 34 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | ZHEJIANG EKSEN MEDICAL TECHNOLOGY CO., LTD | 11 | 2025–2025 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Zhejiang Eksen Medical Technology Co., Ltd | 9 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | ZHEJIANG EKSEN MEDICAL TECHNOLOGY CO., LTD | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Zhejiang Eksen Medical Technology Co., Ltd. | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Zhejiang Eksen Medical Technology Co., Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | Screw Expansion; Orthodontic Expansion Screws; Orthodontic Appliance | 2024 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Wire | 2019 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Tube | 2019 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Elastics | 2019 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Band | 2019 |
| Orthodontic Band SetterECR · Class 1 | Dental hand instruments | Maker | Orthodontic Hooks | 2019 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | LeapBar Class II Malocclusion; Bite Corrector; LeapBar Class III Appliance; LeapBar Class III Corrector;LeapBar Class III Malocclusion; Palatal ExpanderOrthodontic Bracket; Lingual Button; LeapBar Class II Appliance; LeapBar Class II Corrector; | 2019 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Root Canal Files | 2019 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | Orthodontic Plier | 2019 |
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 |
|---|---|---|
| ZHEJIANG EKSEN MEDICAL TECHNOLOGY CO., LTDFDA reg. 3015276158 | Huzhou Zhejiang, China | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10059984). 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.