Data / Medical devices / Ireland / Proverum Limited
Proverum Limited: FDA-registered device maker in Galway Galway(County), Ireland, 1 510(k) clearance and 1 PMA approval
Proverum Limited is registered with the FDA (registration 3038132878) in Galway Galway(County), Ireland. It lists 2 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated December 9, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038132878
- Address
- Unit 3 Ballybrit Business Park, Galway Galway(County), Ireland, H91 DT7C
- Owner or operator
- ProVerum Limited (10094332)
- Roles
- Manufacturer
- First device listed
- November 24, 2025
- Registered through
- 2026
- Brand names listed
- ProVee System for BPH, ProVee Video Processing Unit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | 2 | Manufacturer | accessdata.fda.gov |
| Stent, Urethral, Prostatic, Permanent Or Semi-Permanent | MER | 3 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 24, 2025 | K251734 | ProVee Video Processing Unit (PV-003) | FET | Substantially Equivalent | Proverum Limited | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 9, 2025 | P250011 | ProVee System for BPH | MER | 5 | September 24, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Stent, Urethral, Prostatic, Permanent Or Semi-Permanent
- All makers of Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Updated September 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.