Manufacturer registered with FDA
AMSINO MEDICAL (SHANGHAI) Co., LTD.
SHANGHAI, China. 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
- 514 registrations outside the US
- Establishments
- 1China
Registered in 5 markets
Where regulators' registries name AMSINO MEDICAL (SHANGHAI) 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 | AMSINO MEDICAL (SHANGHAI) Co., LTD. | 1 device types | — | Below |
| Colombia | INVIMA | Manufacturer | AMSINO MEDICAL (SHANGHAI) CO., LTD. | 4 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | AMSINO MEDICAL (SHANGHAI) CO., LTD.AMSINO MEDICAL (SHANGHAI) Co., LTD. | 4 | 2025–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | AMSINO MEDICAL (SHANGHAI) CO., LTD.Amsino Medical (Shanghai) Co., Ltd. | 4 | 2007–2023 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | AMSINO MEDICAL (SHANGHAI) CO. LTD.AMSINO MEDICAL (SHANGHAI) CO., LTD. | 2 | — | 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 AMSINO MEDICAL (SHANGHAI) 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 Hygiene KitNXZ · Class 1 | — | Maker | — | 2021 |
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 |
|---|---|---|
| AMSINO MEDICAL (SHANGHAI) CO., LTD.FDA reg. 3005515211 | SHANGHAI, China | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9080886). 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.