Manufacturer registered with FDA
Shanghai Bing Fan Industrial Co Ltd
shanghai, 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
- 58 registrations outside the US
- Establishments
- 1China
Registered in 5 markets
Where regulators' registries name Shanghai Bing Fan Industrial 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 | Shanghai Bing Fan Industrial Co Ltd | 1 device types | — | Below |
| Australia | TGA | Manufacturer | Shanghai Bing Fan Industrial Co Ltd | 4 | 2019–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SHANGHAI BINGFAN INDUSTRIAL CO., LTD | 2 | 2018–2021 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | SHANGHAI BING FAN INDUSTRIAL CO.,LTD. | 1 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | SHANGHAI BING FAN INDUSTRIAL 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 Shanghai Bing Fan Industrial 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 |
|---|---|---|---|---|
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | HeatSleeve | 2015 |
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 |
|---|---|---|
| SHANGHAI BING FAN INDUSTRIAL CO.,LTD.FDA reg. 3009960170 | SHANGHAI, China | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10047539). 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.