Data / Medical devices / Ireland / Proverum Limited
Proverum Limited: FDA-registered device maker in DUBLIN 1 Dublin(County), Ireland, 1 510(k) clearance and 1 PMA approval
Proverum Limited is registered with the FDA (registration 3017896224) in DUBLIN 1 Dublin(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
- 3017896224
- Address
- 2ND Floor Astor Hall 4-8 Eden Quay, DUBLIN 1 Dublin(County), Ireland, D01 N5W8
- Owner or operator
- ProVerum Limited (10094183)
- Roles
- Specification developer
- First device listed
- November 18, 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 | Specification developer | accessdata.fda.gov |
| Stent, Urethral, Prostatic, Permanent Or Semi-Permanent | MER | 3 | Specification developer | 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 Endoscopic Video Imaging System/Component, Gastroenterology-Urology
- All makers of Stent, Urethral, Prostatic, Permanent Or Semi-Permanent
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.