Data / Medical devices / Taiwan / Fortis Biosolutions Company Limited
Fortis Biosolutions Company Limited: FDA-registered device maker in Taoyuan, Taiwan, 1 510(k) clearance
Fortis Biosolutions Company Limited is registered with the FDA (registration 3045750327) in Taoyuan, Taiwan. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 14, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3045750327
- Address
- No. 121, Ln. 215, Gaoyang S. Rd., Longtan Dist., Taoyuan, Taiwan, 325
- Owner or operator
- Fortis Biosolutions Company Limited (10095976)
- Roles
- Manufacturer
- First device listed
- June 3, 2026
- Registered through
- 2026
- Brand names listed
- Disposable Syringes with Accessories for Power Injectors
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Injector And Syringe, Angiographic | DXT | 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 |
|---|---|---|---|---|---|---|
| May 14, 2026 | K252652 | Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable Syr | DXT | Substantially Equivalent | Fortis Biosolutions Company Limited | accessdata.fda.gov |
Compare with other makers
Updated May 14, 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.