Data / Medical devices / China / Hangzhou Thales Medtech Co., Ltd.
Hangzhou Thales Medtech Co., Ltd.: FDA-registered device maker in Hangzhou Zhejiang, China, 1 510(k) clearance
Hangzhou Thales Medtech Co., Ltd. is registered with the FDA (registration 3023272670) in Hangzhou Zhejiang, China. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 3, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3023272670
- Address
- 2-3rd Floors, Building 2, Shanjing Technology Center, No. 167 Yunzhan Road, Zhuantang Street, Xihu District, Hangzhou Zhejiang, China, 310000
- Owner or operator
- Hangzhou Thales Medtech Co., Ltd. (10085109)
- Roles
- Manufacturer
- First device listed
- May 6, 2022
- Registered through
- 2026
- Brand names listed
- Additive Manufacturing Zirconia Customized Restoration, Zirconia Restoration
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powder, Porcelain | EIH | 2 | Manufacturer | accessdata.fda.gov |
| Teeth, Artificial, Posterior With Metal Insert | ELJ | 1 | Manufacturer | accessdata.fda.gov |
| Teeth, Porcelain | ELL | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 3, 2024 | K240586 | Additive Manufacturing Zirconia Customized Restoration | ELL | Substantially Equivalent | Hangzhou Thales Medtech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Teeth, Artificial, Posterior With Metal Insert
- All makers of Powder, Porcelain
- All makers of Teeth, Porcelain
Updated October 3, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.