Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017896224

FEI Number

3017896224

Entity Name

PROVERUM LIMITED

City/State/Country

DUBLIN 1, IE

Establishment Address

2ND FLOOR ASTOR HALL, 4-8 EDEN QUAY, DUBLIN 1 D01 N5W8, IE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ProVerum Limited (Owner Number: 10094183)

Owner / Operator Contact Address

2ND FLOOR ASTOR HALL, 4-8 EDEN QUAY, DUBLIN 1, IE-D D01 N5W8, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251734

PMA Number

N/A

All Registered Proprietary Names

ProVee System for BPH ProVee Video Processing Unit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MER	Stent, Urethral, Prostatic, Permanent Or Semi-Permanent	Unknown	Class 3	N/A	2025-12-10
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2025-11-18

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
3038132878	PROVERUM LIMITED	Galway, IE

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3038132878	PROVERUM LIMITED	Galway, IE
3016762717	Parametrik Holdings LLC	Elmsford, NY, US
3005099803	BOSTON SCIENTIFIC CORPORATION	Marlborough, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017896224. Last updated year: 2026. Please use registration number 3017896224 when referencing this establishment in official correspondence.