Manufacturer registered with FDA
Infitek Co., Ltd.
Shanghai, China. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 378 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Infitek 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 | Infitek Co., Ltd. | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Infitek Co., Ltd. | 74 | — | Pure Global AI |
| Tanzania | TMDA | Manufacturer | INFITEK Co., ltd | 4 | 2024–2026 | 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 Infitek 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 |
|---|---|---|---|---|
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | ENT&Ophthalmology Diagnostic EquipmentMouth Mirror | 2023 |
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 |
|---|---|---|
| INFITEK CO., LTD.FDA reg. 3027645317 | Shanghai, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10088387). 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.