Uroval
Country not established
Uroval is a medical device manufacturer, with 3 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) as of 13 Nov 2026.
- Devices
- 3
Registry facts
- Registries
- FDA GUDID 2
- FDA 510(k) 1
- Device classes
- FDA Class II 3
What Uroval makes
Uroval manufactures electromyography (EMG) systems and analytical non-scalp cutaneous leads, including the UROVAL BRS SYSTEM (Model BRS01) and TELESIS (Model PROMO1). These devices are designed for neuromuscular assessment and monitoring, supporting clinical evaluations of muscle function and nerve integrity.
The company’s products are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and UDI databases. The portfolio is regulated in the United States, where the manufacturer is based.
Catalogue
- Registry: GUDID
- Regimes: 510(k) Registry: GUDID
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Uroval have in the registry?
The registry currently lists 3 devices for Uroval. Devices recorded under merged duplicate company entries are counted once.
Which registries list Uroval's devices?
Among its 3 most recently registered devices, Uroval has devices listed in FDA 510(k) (1 device) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Uroval's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Uroval's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Uroval in the registry?
The most recently registered devices listed for Uroval include Uroval BR5338 UDI Not Req as is component, Uroval BRS System and UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1.