Unovex of Denmark
Country not established
- Devices
- 1
What Unovex of Denmark makes
Unovex of Denmark manufactures urine collection bags, designed for short-term and intermittent urinary drainage in clinical and home healthcare settings. These devices are intended for single-use applications, ensuring patient comfort and hygiene during medical procedures or post-operative care.
The company’s urine collection bags fall under FDA Class II regulation and are listed via the 510(k) pathway in the United States. The devices are not authorized in other jurisdictions without additional regulatory clearance. Unovex of Denmark operates from the US.
Catalogue
Urinebag Ref K801021
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Unovex of Denmark have in the registry?
The registry currently lists 1 device for Unovex of Denmark. Devices recorded under merged duplicate company entries are counted once.
Which registries list Unovex of Denmark's devices?
Among its 1 most recently registered device, Unovex of Denmark has devices listed in FDA 510(k) (1 device).
What risk classes do Unovex of Denmark's devices fall under?
Among its 1 most recently registered device, the classes recorded for Unovex of Denmark's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Unovex of Denmark in the registry?
The most recently registered devices listed for Unovex of Denmark include URINEBAG.