Manufacturer registered with FDA
Wenzhou Caretek Medical Device Co., Ltd
Wenzhou, China. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 33 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Wenzhou Caretek Medical Device 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 | Wenzhou Caretek Medical Device Co., Ltd | 1 device types | — | Below |
| South Korea | MFDS | Manufacturer | Wenzhou Caretek Medical Device Co., Ltd.Wenzhou Caretek Medical Device Co.,LTD | 2 | 2015–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | Wenzhou Caretek Medical Device 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 Wenzhou Caretek Medical Device 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 |
|---|---|---|---|---|
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Retractor | 2016 |
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 |
|---|---|---|
| WENZHOU CARETEK MEDICAL DEVICE CO., LTDFDA reg. 3007703436 | Wenzhou Zhejiang, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10029464). 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.