Manufacturer registered with FDA
Shanwei Perfect Medical Instruments Co.,Ltd.
Shanwei, China. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 8109 registrations outside the US
- Establishments
- 1China
Registered in 8 markets
Where regulators' registries name Shanwei Perfect Medical Instruments 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 | Shanwei Perfect Medical Instruments Co.,Ltd. | 4 device types | — | Below |
| Canada | Health Canada | Registration holder | SHANWEI PERFECT MEDICAL INSTRUMENTS CO., LTD. | 67 | 2026–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Shanwei Perfect Medical Instruments Co.,Ltd. | 25 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | SHANWEI PERFECT MEDICAL INSTRUMENTS CO.,LTD. | 8 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SHANWEI PERFECT MEDICAL INSTRUMENTS CO., LTD. | 4 | 2025–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SHANWEI PERFECT MEDICAL INSTRUMENTS CO. | 3 | 2026–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SHANWEI PERFECT MEDICAL INSTRUMENTS CO., LTD | 1 | 2026–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Shanwei Perfect Medical Instruments Co., Ltd | 1 | 2024–2024 | 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 Shanwei Perfect Medical Instruments 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 |
|---|---|---|---|---|
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Gutta Percha Cutting Pen | 2026 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | Gutta Percha Points | 2025 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Dental Root-canal Instruments | 2025 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | Ultrasonic Irrigation Activator | 2026 |
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 |
|---|---|---|
| SHANWEI PERFECT MEDICAL INSTRUMENTS CO.,LTD.FDA reg. 3042283835 | Shanwei Guangdong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10094449). 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.