Data / Medical devices / China / Hunan Hualian Special Ceramics Co., Ltd
Hunan Hualian Special Ceramics Co., Ltd: FDA-registered device maker in Zhuzhou Hunan, China, 1 510(k) clearance
Hunan Hualian Special Ceramics Co., Ltd is registered with the FDA (registration 3034605324) in Zhuzhou Hunan, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 9, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3034605324
- Address
- Hunan Province Liling Economic Development Zone Innovation Park II, Zhuzhou Hunan, China, 412299
- Owner or operator
- Hunan Hualian Special Ceramics Co., Ltd (10091994)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- November 23, 2024
- Registered through
- 2027
- Brand names listed
- Powder, Porcelain, Zirconia Block
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powder, Porcelain | EIH | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| July 9, 2024 | K241316 | Zirconia Block | EIH | Substantially Equivalent | Hunan Hualian Special Ceramics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 9, 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.