Data / Medical devices / China / Hangzhou Ivista Medical Devices Co., Ltd
Hangzhou Ivista Medical Devices Co., Ltd: FDA-registered device maker in Hangzhou Zhejiang, China, 1 510(k) clearance
Hangzhou Ivista Medical Devices Co., Ltd is registered with the FDA (registration 3030536692) in Hangzhou Zhejiang, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 12, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030536692
- Address
- No. 7, Chunjiang Road, Qiaonan Development ZoneNingwei Town, Xiaoshan District, Hangzhou Zhejiang, China, 310000
- Owner or operator
- Hangzhou IVISTA Medical Devices Co., Ltd (10089875)
- Roles
- Manufacturer
- First device listed
- January 17, 2024
- Registered through
- 2026
- Brand names listed
- Zirconia Block
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powder, Porcelain | EIH | 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 |
|---|---|---|---|---|---|---|
| January 12, 2024 | K233125 | Zirconia Block | EIH | Substantially Equivalent | Hangzhou Ivista Medical Devices Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated January 12, 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.