Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038132878

FEI Number

3038132878

Entity Name

PROVERUM LIMITED

City/State/Country

Galway, IE

Establishment Address

Unit 3, Ballybrit Business Park, Galway H91 DT7C, IE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ProVerum Limited (Owner Number: 10094332)

Owner / Operator Contact Address

2nd Floor Astor Hall, 4-8 Eden Quay, Dublin 1, IE-D D01N5W8, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P250011

All Registered Proprietary Names

ProVee Video Processing Unit ProVee System for BPH

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2025-11-24
MER	Stent, Urethral, Prostatic, Permanent Or Semi-Permanent	Unknown	Class 3	N/A	2025-12-10

Official Correspondent

Niamh Mahony

US Agent Details

H. Semih Oktay Business: Cardiomed Email: soktay@cardiomedllc.com Phone: (410) 2712088

Related Public Records

Same Entity

ProVerum Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3017896224	PROVERUM LIMITED	DUBLIN 1, IE

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038132878. Last updated year: 2026. Please use registration number 3038132878 when referencing this establishment in official correspondence.