Manufacturer registered with FDA
Ningbo Raffini Import & Export Co., Ltd
Ningbo, China. Lists 7 dental device types with FDA across 1 registered establishment.
- Device types listed
- 7
- Brands and models
- 8
- 510(k) clearances
- 0as applicant
- Markets registered in
- 519 registrations outside the US
- Establishments
- 1China
Registered in 5 markets
Where regulators' registries name Ningbo Raffini Import & Export 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 | Ningbo Raffini Import & Export Co., Ltd | 7 device types | — | Below |
| Australia | TGA | Manufacturer | Ningbo Raffini Import & Export Co Ltd | 14 | 2021–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | NINGBO RAFFINI IMPORT & EXPORT CO LTD | 3 | 2024–2024 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | NINGBO RAFFINI IMPORT & EXPORT CO LTD | 1 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Ningbo Raffini Import & Export 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 Ningbo Raffini Import & Export 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 Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | Water Flossers Electric | 2023 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | TOOTHBRUSH | 2020 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Electric Toothbrush | 2021 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Dental floss | 2023 |
| Fluid-Filled Teething RingKKO · Class 2 | — | Maker | Teething Ring, Ring, Teething, Fluid-Filled53oz/15 grams all natural homeopathic formula citroganix soothing gel with silicone gume-eez teether | 2019 |
| Tongue ScraperLCN · Class 1 | — | Maker | TONGUE SCRAPER | 2021 |
| Teething Ring Non-Fluid FilledMEF · Class 1 | — | Maker | Non-fluid filled silicone teether; Ring, Teething, Non-Fluid Filled | 2020 |
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 |
|---|---|---|
| NINGBO RAFFINI IMPORT & EXPORT CO., LTDFDA reg. 3005980667 | Ningbo Zhejiang, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10061858). 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.