Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015615781

FEI Number

3015615781

Entity Name

SIGNUM SURGICAL LIMITED

City/State/Country

Galway Galway (City), IE

Establishment Address

Signum Surgical Limited, New Docks, Port of Galway, Galway Galway (City) H91NNY6, IE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Signum Surgical Limited (Owner Number: 10092825)

Owner / Operator Contact Address

Signum Surgical Limited, New Docks, Port of Galway, Galway, IE-GA H91NNY6, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN240007

PMA Number

N/A

All Registered Proprietary Names

BioHealx Anal Fistula Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QML	Anal Fistula Closure Device	General, Plastic Surgery	Class 2	878.4835	2025-02-23

Official Correspondent

Moshe Zilversmit

US Agent Details

Carol Burns Email: carol@signumsurgical.com Phone: (650) 8233765

Related Public Records

Same Entity

Signum Surgical 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
3038193698	Signum Surgical USA, Inc.	Wayne, PA, US

Similar Registrations

Registration Number	Establishment Name	Location
3038193698	Signum Surgical USA, Inc.	Wayne, PA, US
3028606342	OMAY(GUANGZHOU) MED TECHNOLOGIES CO., LTD	Guangzhou Guangdong, CN
3038274470	BRAINMATTERZ, INC	McKinney, TX, US
3012404174	LABORATORIO CHIMICO FARMACEUTICO A. SELLA SRL.	Schio Vicenza, IT
3042364673	NEURALYTIX LLC	Fruita, CO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015615781. Last updated year: 2026. Please use registration number 3015615781 when referencing this establishment in official correspondence.