Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004859928

FEI Number

3004859928

Entity Name

PROXY BIOMEDICAL LTD.

City/State/Country

GALWAY, IE

Establishment Address

COILLEACH, SPIDDAL, GALWAY --, IE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Proxy Biomedical Ltd (Owner Number: 9060885)

Owner / Operator Contact Address

Coilleach, Spiddal, Co. Galway, IE-NOTA H91 C2NF, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Upsylon Traditional Y mesh Polyform Synthetic Mesh Upsylon Y-Mesh Kit with Colpassist Vaginal Positioning Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OTO	Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	General, Plastic Surgery	Class 2	878.3300	2013-03-19
OTO	Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	General, Plastic Surgery	Class 2	878.3300	2022-02-17
OHD	Gynecological Laparoscopic Kit	Obstetrics/Gynecology	Class 2	884.1720	2013-07-03

Official Correspondent

Pat Gorman

US Agent Details

Charlene Grilletto Business: Integer Holdings Email: Charlene.Grilletto@integer.net Phone: (215) 5342280

Related Public Records

Same Entity

Proxy Biomedical Ltd

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004859928. Last updated year: 2026. Please use registration number 3004859928 when referencing this establishment in official correspondence.