Urodynamix Technologies, Ltd.
CanadaFDA 510(k) applicant, unverified
- Devices
- 1
What Urodynamix Technologies, Ltd. makes
Urodynamix Technologies, Ltd. manufactures the URONIRS, Model 2000, a device used for urodynamic testing to assess bladder function and diagnose conditions such as urinary incontinence or voiding dysfunction.
The company’s portfolio is regulated under FDA Class II devices and requires 510(k) clearance. The URONIRS, Model 2000 is listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Uronirs, Model 2000 Ref K082701
510(k) 510(k)
Frequently asked questions
How many devices does Urodynamix Technologies, Ltd. have in the registry?
The registry currently lists 1 device for Urodynamix Technologies, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Urodynamix Technologies, Ltd.'s devices?
Among its 1 most recently registered device, Urodynamix Technologies, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Urodynamix Technologies, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Urodynamix Technologies, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Urodynamix Technologies, Ltd. in the registry?
The most recently registered devices listed for Urodynamix Technologies, Ltd. include URONIRS, MODEL 2000.