Data / Medical devices / China / Ningbo Ican Machines Co., Ltd.
Ningbo Ican Machines Co., Ltd.: FDA-registered device maker in Ningbo Zhejiang, China, 1 510(k) clearance
Ningbo Ican Machines Co., Ltd. is registered with the FDA (registration 3010684578) in Ningbo Zhejiang, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 6, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010684578
- Address
- No.77 Yunlin East Road, Gulin Town, Haishu District, Ningbo Zhejiang, China, 315176
- Owner or operator
- Ningbo Ican Machines Co., Ltd. (10094502)
- Roles
- Manufacturer
- First device listed
- December 4, 2025
- Registered through
- 2026
- Brand names listed
- 23D Pro, 2545D, 28D Pro, Steam Sterilizer (2545D)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sterilizer, Steam | FLE | 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 |
|---|---|---|---|---|---|---|
| June 6, 2025 | K243994 | Steam Sterilizer (2545D) | FLE | Substantially Equivalent | Ningbo Ican Machines Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated June 6, 2025. 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.