Identity
- Trade Name
- Rivus FDA UDI
- Generic Name
- Urodynamic measurement system FDA UDI
- Device Name
- The uroflowmeter is intended to quantify the flow characteristics of the lower urinary tract. The uroflowmetry is used for patients with urinary incontinence, abnormal urinary retention. FDA UDI
- Model / Reference
- Rivus FDA UDI
- Description
- The uroflowmeter is intended to quantify the flow characteristics of the lower urinary tract. The uroflowmetry is used for patients with urinary incontinence, abnormal urinary retention. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04650075339992 FDA UDI
- FDA Product Code
- EXY FDA UDI
- GMDN Term
- Urodynamic measurement system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Rivus by Neurosoft, Ooo — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Neurosoft, Ooo
Sources (1)
- FDA UDI 5f832bd9-9a67-40e8-89d7-3391d93cec02 34 fields · synced May 29, 2026