URODYNAMICS DEVICES - OTHER
Basic Information
- Primary DI
- B408IF20
- Basic UDI-DI Code
- B-B408IF20
- Reference
- IF2
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 1
- Status
- On The Market
- Manufacturer
- Kesem Health Pty Ltd
Additional Description
The iUFlow device consists of a sensor attached to the underside of a disposable urine bowl. The device is installed on the user’s toilet, between the toilet seat and the toilet bowl. The device is connected to the user’s smartphone / tablet via Bluetooth. The iUFlow software application must be installed on the smartphone / tablet in order to download voiding events from the iUFlow sensor. During a voiding event by the user, urine is directed into the inlet of the urine bowl. The flow of urine then passes through the sensor. The sensor is measuring changes in urine height. The iUFlow software application on the smartphone / tablet converts the sensor signal to a voiding event profile with summary statistics including flow volume, average flow, flow time, voiding time etc. This information is recorded in a diary format by the iUFlow application to be used by the physician. The device is not supplied in sterile condition and is not radioactive.
CND Nomenclature Codes
| Code | Description |
|---|---|
| U0599 | URODYNAMICS DEVICES - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex V | CE694938 | BSI Group The Netherlands B.V. | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDD).