Registered with FDA
Alfresa Pharma Corporation
CHUO-KU, Japan. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 632 registrations outside the US
- Establishments
- 1Japan
Registered in 6 markets
Where regulators' registries name Alfresa Pharma Corporation as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | Alfresa Pharma Corporation | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Alfresa Pharma Corporation | 13 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | ALFRESA PHARMA CORPORATION | 10 | 2010–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Alfresa Pharma Corporation | 7 | 2002–2025 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Alfresa Pharma Corporation | 1 | 2026–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ALFRESA PHARMA CORPORATION | 1 | 2020–2020 | 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 Alfresa Pharma Corporation currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Lister | — | 2013 |
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 |
|---|---|---|
| Alfresa Pharma CorporationFDA reg. 3008490140 | CHUO-KU Osaka, Japan | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10044070). 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.