Manufacturer registered with FDA
Tianjin Tairuibosi Medical Appliance Co.,Ltd
Tianjin, 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
- 613 registrations outside the US
- Establishments
- 1China
Registered in 6 markets
Where regulators' registries name Tianjin Tairuibosi Medical Appliance 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 | Tianjin Tairuibosi Medical Appliance Co.,Ltd | 1 device types | — | Below |
| Brazil | ANVISA | Manufacturer | TIANJIN TAIRUIBOSI MEDICAL APPLIANCE CO., LTD | 5 | 2024–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | TIANJIN TAIRUIBOSI MEDICAL APPLIANCE CO., LTD. | 4 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | TIANJIN TAIRUIBOSI MEDICAL APPLIANCE CO.,LTDTIANJIN TAIRUIBOSI MEDICAL APPLIANCE CO.,LTD. | 2 | 2025–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | Tianjin Tairuibosi Medical Appliance Co.,Ltd | 1 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Tianjin Tairuibosi Medical Appliance 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 Tianjin Tairuibosi Medical Appliance 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 |
|---|---|---|---|---|
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Impression Foam Box | 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 |
|---|---|---|
| TIANJIN TAIRUIBOSI MEDICAL APPLIANCE CO., LTD.FDA reg. 3016147813 | Tianjin, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10061898). 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.