Identity
- Trade Name
- iUFlow FDA UDI
- Generic Name
- Urine flowmeter, reusable FDA UDI
- Device Name
- iUFlow EUDAMEDA uroflowmeter for measurement of urination (voiding) frequency, volume and flowrate of patients suffering from Lower Urinary Tract Symptoms (LUTS) when used in conjunction with the iUFlow mobile application. FDA UDI
- Model / Reference
- IF2 EUDAMEDFDA UDI
- Description
- A uroflowmeter for measurement of urination (voiding) frequency, volume and flowrate of patients suffering from Lower Urinary Tract Symptoms (LUTS) when used in conjunction with the iUFlow mobile application. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B408IF20 EUDAMEDFDA UDI
- Basic UDI-DI
- B-B408IF20 EUDAMED
- FDA Product Code
- EXY FDA UDI
- EMDN Code
- U0599 URODYNAMICS DEVICES - OTHER EUDAMED
- GMDN Term
- Urine flowmeter, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1800 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
iUFlow by Kesem Health Pty Ltd — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-B408IF20 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kesem Health Pty Ltd
- EUDAMED SRN
- AU-MF-000019211
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (2)
- EUDAMED 4584899f-afc1-42c7-bc21-e41960ac56d1 61 fields · synced Oct 6, 2026
- FDA UDI 9721f34e-0c04-4b30-9f22-e23b388f0f95 34 fields · synced May 29, 2026