Data / Medical devices / Taiwan / Sturdy Industrial Co., Ltd.
Sturdy Industrial Co., Ltd.: FDA-registered device maker in New Taipei City, Taiwan, 2 510(k) clearances
Sturdy Industrial Co., Ltd. is registered with the FDA (registration 3007515605) in New Taipei City, Taiwan. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated June 21, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007515605
- Address
- No. 168, Sec. 1, Zhongxing RD., Wugu District, New Taipei City, Taiwan, 24872
- Owner or operator
- STURDY INDUSTRIAL CO., LTD. (10061891)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- November 29, 2019
- Registered through
- 2026
- Brand names listed
- AGNeovo Autoclave LouieP Series (model: P-M10T), AGNeovo Autoclave LouieP Series (model: P-M10TR), STURDY Autoclave Super Microm (Model: SA-260MA), STURDY Autoclave Super Microm (Model: SA-260MA-R), STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sterilizer, Steam | FLE | 2 | Complaint file establishment, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| June 21, 2023 | K231489 | Sturdy Autoclave Super Microm | FLE | Substantially Equivalent | Sturdy Industrial Co., Ltd. | accessdata.fda.gov |
| November 1, 2019 | K181993 | STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) | FLE | Substantially Equivalent | Sturdy Industrial Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated June 21, 2023. 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.