Wintecare SA
SwitzerlandFDA applicant, unverified FDA FEI 3013517192
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Wintecare SA makes
Wintecare SA manufactures the T-PLUS, a medical device designed for [specific application not detailed in provided data]. This product is intended for [clinical use or purpose not specified, but implied as a regulated Class II device].
The T-PLUS is classified as a Class II device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
T-Plus Ref K181893
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3013517192
- Address
- Via Motta 10, Chiasso Ticino
Frequently asked questions
How many devices does Wintecare SA have in the registry?
The registry currently lists 1 device for Wintecare SA. Devices recorded under merged duplicate company entries are counted once.
Which registries list Wintecare SA's devices?
Among its 1 most recently registered device, Wintecare SA has devices listed in FDA 510(k) (1 device).
What risk classes do Wintecare SA's devices fall under?
Among its 1 most recently registered device, the classes recorded for Wintecare SA's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Wintecare SA in the registry?
The most recently registered devices listed for Wintecare SA include T-PLUS.