Fortis Biosolutions Company Limited
TaiwanFDA applicant, unverified FDA FEI 3045750327
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Fortis Biosolutions Company Limited makes
The company manufactures disposable syringes designed for use with power injectors, including variants with specific accessory configurations for medical imaging and diagnostic procedures.
These devices are classified as Class II under global regulatory frameworks and are listed via FDA 510(k) premarket notifications. The manufacturer is based in Taiwan.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3045750327
- Address
- No. 121, Ln. 215, Gaoyang S. Rd., Longtan Dist.,, Taoyuan
Frequently asked questions
How many devices does Fortis Biosolutions Company Limited have in the registry?
The registry currently lists 1 device for Fortis Biosolutions Company Limited. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fortis Biosolutions Company Limited's devices?
Among its 1 most recently registered device, Fortis Biosolutions Company Limited has devices listed in FDA 510(k) (1 device).
What risk classes do Fortis Biosolutions Company Limited's devices fall under?
Among its 1 most recently registered device, the classes recorded for Fortis Biosolutions Company Limited's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Fortis Biosolutions Company Limited in the registry?
The most recently registered devices listed for Fortis Biosolutions Company Limited include 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.