Manufacturer registered with FDA
Wenzhou KLF Medical Plastics 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
- 959 registrations outside the US
- Establishments
- 1China
Registered in 9 markets
Where regulators' registries name Wenzhou KLF Medical Plastics 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 KLF Medical Plastics Co Ltd | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Wenzhou K.L.F. Medical Plastics Co., Ltd | 18 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | WENZHOU KLF MEDICAL PLASTICS CO.LTDAWENZHOU K.L.F. MEDICAL PLASTICS CO., LTD. | 11 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | WENZHOU K.L.F. MEDICAL PLASTICS CO., LTD.WENZHOU K L.F. MEDICAL PLASTICS CO., LTD. | 11 | 2008–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | WENZHOU K.L.F. MEDICAL PLASTICS CO.LTD.Wenzhou K.L.F Medical Plastics Co Ltd · Wenzhou K.L.F Medical Plastics Co.Ltd. · +1 | 5 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Wenzhou K.L.F Medical Plastics Co., LtdWENZHOU KLF MEDICAL PLASTICS CO.,LTD | 5 | 2016–2019 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Wenzhou K.L.F. Medical Plastics Co, Ltd | 4 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Wenzhou KLF Medical Plastics Co Ltd | 3 | 2024–2024 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | WENZHOU K.L.F. MEDICAL PLASTICS CO., LTD. | 2 | 2011–2019 | 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 KLF Medical Plastics 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 |
|---|---|---|---|---|
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | Evacuator | 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 K.L.F. MEDICAL PLASTICS CO., LTD.FDA reg. 3004538333 | WENZHOU Zhejiang, China | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9062855). 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.