Data / Medical devices / Taiwan / Savfe Co., Ltd.
Savfe Co., Ltd.: FDA-registered device maker in New Taipei City, Taiwan, 1 510(k) clearance
Savfe Co., Ltd. is registered with the FDA (registration 3047907228) in New Taipei City, Taiwan. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 11, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3047907228
- Address
- 2 F., No. 89, Qiaohe Rd. Zhonghe Dist., New Taipei City, Taiwan, 235030
- Owner or operator
- SAVFE Co., Ltd. (10096122)
- Roles
- Manufacturer
- First device listed
- June 30, 2026
- Registered through
- 2026
- Brand names listed
- ArmSure Fluoroscopic Positioning System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Interventional Fluoroscopic X-Ray System | OWB | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | 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 |
|---|---|---|---|---|---|---|
| February 11, 2026 | K251992 | ArmSure Fluoroscopic Positioning System | OWB | Substantially Equivalent | Savfe Co. , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of System, X-Ray, Fluoroscopic, Image-Intensified
- All makers of Interventional Fluoroscopic X-Ray System
Updated February 11, 2026. 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.